The “synactive” theory of neurobehavioral development forms the basis of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Our objective was to assess the effectiveness of NIDCAP in improving outcomes in preterm infants.
Medline, CINAHL, Embase, PsychInfo, The Cochrane Library, Pediatric Academic Societies’ Abstracts and Web of Science were searched in July 2010 and February 2012. The studies selected were randomized controlled trials testing the effectiveness of NIDCAP on medical and neurodevelopmental outcomes. The authors abstracted baseline characteristics of infants and outcomes. The risk of bias was assessed by using Cochrane criteria. RevMan 5.1 was used to synthesize data by the use of relative risk and risk difference for dichotomous outcomes and mean or standardized mean difference for continuous outcomes.
Eleven primary and 7 secondary studies enrolling 627 neonates were included, with 2 of high quality. The composite primary outcomes of death or major sensorineural disability at 18 months corrected age or later in childhood (3 trials, 302 children; relative risk 0.89 [95% confidence interval 0.61 to 1.29]) and survival free of disability at 18 months corrected age or later in childhood (2 trials, 192 infants; relative risk 0.97 [95% confidence interval 0.69 to 1.35]), were not significantly different between the NIDCAP and control groups. With the sensitivity analysis that excluded the 2 statistically heterogeneous outlying studies, there were no significant differences between groups for short-term medical outcomes.
This systematic review including 627 preterm infants did not find any evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcomes.
Comments
North and South American Neonatologists Respond to NIDCAP Meta-analysis
We the undersigned 75 neonatologists and psychologists from the Americas thank Ohlsson and Jacobs for again evaluating the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) for organized developmentally appropriate, family-centered care of fragile premature newborns (Pediatrics 2013; 131:3, e881-e893).
Meta-analysis requires the pooling and evaluation of RCTs that are comparable in their study populations, design and outcome variables. This is not the case in this most recent review. The authors have also inappropriately included studies of questionable quality or extremely short duration of treatment. Those seeking to evaluate NIDCAP should note, as Ohlsson and Jacobs point out, that carefully done NIDCAP studies with quite large sample sizes (1,2)have demonstrated statistically significant benefits of great clinical significance. Specifically NIDCAP-directed care has produced shorter hospital stays (with reduced hospital costs), discharges from the hospital by infants younger than their non-NIDCAP peers, and better neurodevelopmental outcomes at 2 weeks and 9 months corrected age by Assessment of Preterm Infant Behavior (APIB) and Bayley II evaluation. Given these positive outcomes of NIDCAP shown by their meta-analysis, it is surprising that the authors then conclude that "NIDCAP cannot be recommended for very preterm infants".
Other methodologically sound studies show positive effects of NIDCAP on brain structureal and function.(3-7) These include increased myelinization of brain, greater neural connectivity and coherence of brain activity, compared to controls. These results reflect a pattern of improving brain maturation. Moreover, these effects are measurable beyond the inevitable spillover of NIDCAP treatment into the control group, with no demonstrable ill effects or complications. These studies are appropriately omitted from the meta-analysis because of their differing designs and outcomes, but these findings are highly relevant to the clinical question "Does NIDCAP work?"
Most importantly, as always, absence of proof (at the alpha<0.05 level) does not constitute proof of absence (of beneficial effects). Ohlsson and Jacobs "cannot recommend NIDCAP" based on their problematic meta-analysis. We CAN AND DO recommend NIDCAP, based on the evidence cited above and on our years of experience with its systematic protection of fragile infants, its direction and enrichment of bedside care and the teams who provide it, and its tremendous enhancement of parents' comfort and capability for assuming their essential role in their child's life from the very beginning. We do not know which subcomponents of the comprehensive intervention produce which results, but the NIDCAP approach is far too important and promising to abandon based on questionable meta- analyses. It is a human and humane approach to our specialty, one that appears to offer great benefits in outcome, and one that has not shown a single negative side effect.
Some neonatologists may find it difficult to accept that behavioral and parenting methods can improve the outcomes of our highly technical NICU care, but we suggest that these methods have the power to blunt some of the hardships of the NICU (for both infants and parents, not to mention staff), and may allow our NICU care to rise to new heights of successful rescue and quality survival.
1. Als H, Gilkerson L, Duffy FH, et al. A three-center randomized controlled trial of individualized developmental care for very low birth weight preterm infants: Medical, neurodevelopmental, parenting and caregiving effects. Journal of Developmental and Behavioral Pediatrics. 2003;24(6):399-408. 2. Peters K, Rosychuk R, Hendson L, Cote J, McPherson C, Tyebkhan J. Improvement of short- and long-term outcomes for very low birth weight infants: The Edmonton NIDCAP trial. Pediatrics. 2009;124:1009-1020. 3. Als H, Duffy F, McAnulty GB, et al. Early experience alters brain function and structure. Pediatrics. 2004;113(4):846-857. 4. McAnulty G, Duffy F, Butler S, et al. Individualized developmental care for a large sample of very preterm infants: Health, neurobehavior and neurophysiology. Acta Paediatr. 2009;98:1920-1926. 5. McAnulty G, Duffy F, Butler S, Bernstein J, Zurakowski D, Als H. Effects of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) at age 8 years: Preliminary data. Clin Pediatr. 2010;49(3):258-270. 6. Als H, Duffy FH, McAnulty GB, et al. Is the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) effective for preterm infants with intrauterine growth restriction? J. Perinatol. 2011;31(2):130 -136. 7. Als H, Duffy FH, McAnulty G, et al. NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol. 2012;32:797-803.
Conflict of Interest:
None declared
Re:Re:Re: Ohlsson and Jacobs, NIDCAP: A Systematic Review and Meta-analyses
Conflict of Interest:
PreemieWorld, LLC Preemie Magazine
Re:Re: Ohlsson and Jacobs, NIDCAP: A Systematic Review and Meta-analyses
To the Editors,
We appreciate the interest in our systematic review on NIDCAP (1), much from readers involved with NIDCAP who declare their conflict of interest (2-5). We provide a single response to the four separate, but overlapping, e-Letters (2-5).
We are neonatologists with expertise in creating and evaluating evidence, and whilst one of us (AO) has undergone basic NIDCAP training by Dr. Als at Women's College Hospital in Toronto, Ontario, Canada, we are not NIDCAP experts and have no conflict of interest to declare. As stated in 2002 (6) and again in our recent review: "Modification of the extrauterine NICU environment and care giving according to each infant's current physiologic and neurobehavioral functioning is a rational and intuitive approach to caring for preterm infants and their families and to supporting infant development" (1). Like our readers, we strongly endorse and practice humane, developmentally supportive, gentle care (2-5) that recognizes and engages the family as their baby's primary caregiver. Where we disagree, is around the lack of evidence from this systematic review of 11 randomized controlled trials involving 627 neonates for NIDCAP to be the only framework upon which to provide care for these vulnerable babies and families.
Recent independent critical appraisals published in Evidence Updates (from the BMJ Evidence Centre and McMaster University) (7) contradict these e-Letters to support our systematic review findings. The clinical rater for Pediatric Hospital Medicine writes: "This is an important article which poses 2 clear questions and answers them emphatically" (7). For Pediatric Neonatology the rater writes: "Good article summarizing the key evidence well. I previously thought that NIDCAP had been associated with improved short term outcomes. The data is well presented and easy to assimilate. This is useful as training staff to use NIDCAP is expensive and I would need to see evidence of benefit before committing to this" (7). The reviewer for Pediatrics (General) writes: "Interesting. Clear evidence of no benefit. It is rare that we get such conclusive results from a meta analysis. Very important to know because NIDCAP is a very labour and resource intensive intervention" (7).
We apologize for our error and unfortunate choice of wording when we stated that the NIDCAP assessment "requires trained and certified caregivers to use the Assessment of Premature Infant Behavior (APIB) tool to observe 91 neonatal behaviors every 2 minutes for 1 hour before, during, and after a care giving intervention"(1). As detailed in our previous reviews (6, 8, 9), we are well aware that although they are related the APIB and NIDCAP assessments differ. The term NIDCAP was not used in the first phase-lag study of the intervention published in 1986 (10). Dr. Als wrote: "The behavioral observation sheet (Figure. Behavioral observation sheet) is based on the conceptualization of the Assessment of Preterm Infant's Behavior (APIB)"(10). We apologize for using the incorrect term 'Prechtl's General Movement Assessment' in the introduction, instead of 'The Prechtl Neurological Assessment of the Fullterm Newborn Infant', which is what was reported in the included studies, (11-14) and which we correctly referenced (15) in our systematic review (1). We thank the readers for drawing our attention to these oversights and we have rectified them in a separate erratum that was submitted to the Editors of Pediatrics on April 9, 2013. These two errors in terminology do not affect the validity of the methods or the results of our systematic review. Importantly, "To be included in the review, the intervention had to be NIDCAP as described by Dr. Als and applied to low- birth-weight or preterm infants while in the hospital". "The intervention had to be tested in a randomized controlled trial (RCT) design and compared with standard care". (1)
Randomized controlled trials and systematic reviews provide the most valid results on which to build an evidence-based perinatal practice (16). We acknowledge the work by Dr. Als and all the authors of the studies included in this systematic review, who recognized the importance of using RCT methodology to evaluate the effectiveness of NIDCAP in improving outcomes. This has enabled us to summarize the evidence from a larger sample of preterm infants than in previous reviews and provide more precise estimates of effect sizes. We too have been and are involved in the design, conduct, analysis and interpretation of many neonatal RCTs (17 -19), and systematic reviews undertaken to identify effective interventions (20, 21) and to inform practice guidelines including management of stress and pain in newborns (22, 23). Several of these trials have provided evidence of beneficial outcomes, and in contrast to Dr. Lawhon's assertions, translation of this knowledge has entailed us changing clinical practice (17, 18, 20-23).
We used standard Cochrane methods for conducting this and previous systematic reviews on NIDCAP (24). Cochrane states "Main outcomes should generally not include surrogate or interim outcomes. They should not be chosen on the basis of any anticipated or observed magnitude of effect, or because they are likely to have been addressed in the studies to be reviewed" (24). "In addition, indirect or surrogate outcome measures, such as laboratory results or radiologic results (e.g. loss of bone mineral content as a surrogate for fractures in hormone replacement therapy), are potentially misleading and should be avoided or interpreted with caution because they may not predict clinically important outcomes accurately" (24). Therefore, in accordance with Cochrane methodology, transverse relaxation time and diffusion tensor magnetic resonance imaging (MRI) and sleep cortical spectral coherence electroencephalogram (EEG) were not reported in our systematic review.
The primary outcome for this systematic review was selected on the basis of our review questions, which support Dr. Als' stated NIDCAP goal 'to improve neurodevelopmental functioning' (2). "The composite of death or major sensorineural disability at 18 months corrected age (CA) or later in childhood" is considered an important primary outcome in neonatal RCTs and systematic reviews (17-21, 25). This is consistent with the 1993 care- giving review by Lacy (Occupational therapist) and Ohlsson, published before any NIDCAP RCTs had been conducted, stating "follow-up should be extended to school age" (26), and recognized by NIDCAP researchers with the results included in our systematic review (27, 28) and even reported since publication of our review (29).
Death should be reported in all neonatal trials following randomization, with all infants randomized accounted for on an intention- to-treat basis. Mortality was reported in four RCTs enrolling 354 infants in this review (Table 3). We could not include the 18 deaths that occurred in Dr. Als and colleagues three-center study, as deaths were not reported per NIDCAP and control groups (30). The authors reported outcomes only for the 92 surviving infants among the 110 infants enrolled (30). Any RCT evaluating an intervention in newborn infants, particularly a developmentally sensitive intervention in preterm infants, should report on neurodevelopmental outcomes at 18 months or later. Our review included short-term medical and developmental outcomes previously evaluated and reported by Drs. Als, Lawhon and colleagues (10), with similar outcomes reported in all RCTs to date. We are a little confused that Dr. Lawhon and colleagues disagree with us including short-term medical outcomes such as "in hospital deaths, chronic lung disease, necrotizing enterocolitis intraventricular hemorrhage and like. In, contrast, NIDCAP is aimed at a different array of important targets" (4).
Meta-analyses using the Cochrane statistical package RevMan give weight in the analysis of risk ratio for an included study only if the outcome of interest occurred in at least one infant (case) in either the control group, or the study group (31). Therefore, in studies in which there were no cases in either the NIDCAP or the control group for outcomes such as intraventricular hemorrhage and retinopathy of prematurity, the study was not given any weight in the meta-analysis. Similarly, only data from ventilated infants were included in the outcome 'days of assisted ventilation via an endotracheal tube' (Table 3).
We report the findings of our data collection and analyses in an unbiased fashion in the results section (information). In the discussion section we interpret and use judgment to assess the clinical relevance of this information (knowledge translation) (32). The readers of our review have focused on the few statistically significant results and ignored the statistically non-significant findings in Tables 2 and 3, our interpretation of these findings in the discussion section, as well as the supplemental information about the baseline characteristics and the numerous serious issues related to bias (Supplemental Appendix 2, Risk of Bias in Included Studies) (1). These include the exceedingly long time lapses between recruitment and publication of the results (14), trial registration in all included studies only after the last patient was recruited and in Dr. Als and co-workers 2 latest studies an unexplained imbalance between the numbers of infants randomized to the NIDCAP and the control groups (33, 34). In the 2011 report there were 12 infants in the NIDCAP group and 18 in the control group (33). In the 2012 report there were 13 infants in the NIDCAP group and 17 in the control group (34). Did the difference of a total of 10 more infants enrolled in the control groups compared with the NIDCAP groups in these very small trials happen by chance? Although the 2 studies have the same NCT registration number (NCT00914108) we assumed they were different studies as different recruitment periods were reported. As researchers conducting meta-analyses we have to be careful not to include outcome data from the same infant twice, but this has been difficult. More recently, the 9-year outcomes were published for 23 infants from the 2011 report (33) (9 children in the NIDCAP group and 14 in the control group; 23 % lost to follow up) (29). The study has the same NCT number (NCT00914108) as the 2 previous studies from 2011 (33) and 2012 (34).
In Supplemental Appendix 3 we report on the weighted mean difference for each of the 6 system scores for the APIB on 281 enrolled infants at 2 weeks corrected age. The weighted mean difference in the APIB scores range from -0.53 for 'Attention system' to -0.88 for 'Examiner facilitation'. Although statistically significant, these differences between the groups of less than 1 point on a 9-point scale (35) cannot be considered clinically important.
None of the e-Letter writers acknowledge the statistically significant, but clinically unimportant differences between the groups. The standardized mean differences in Bayley Mental Developmental Index and Psychomotor Development Index at 9 months of 1 point or less, although statistically significant, cannot be considered clinically important, especially as significant differences were not found at earlier or later ages (Table 2). Similarly, the 1.5 g/day (0.05 oz/day) difference in in- hospital weight gain between the groups while statistically significant is not clinically meaningful, especially with no difference in weights noted at term or 2 weeks, or at 9, 12 or 24 months of age corrected for preterm birth (Table 4). The e-Letter writers totally disregard the important outcomes that were not statistically significantly different between groups (Table 3 and Supplemental Appendix 4 Sleep Outcomes). These include chronic lung disease at 36 weeks post menstrual age (PMA), intraventricular hemorrhage, sepsis, retinopathy of prematurity, necrotizing enterocolitis, days in supplemental oxygen, days on assisted ventilation, and sleep outcomes at 36 weeks PMA and 3 months corrected age which have often been claimed to be favorably affected by NIDCAP. With the increased sample size in this review (n = 627) compared with our 2002 review (n = 136), the outcomes of duration of ventilation and supplemental oxygen were no longer statistically significant, and weight gain was reduced from 3.2 to 1.5 g/d (1, 6).
We report a 6-day reduction in length of hospitalization with a related 0.5-week reduction in PMA at discharge (the p-value is 0.04 but the upper 95% confidence interval includes 0 weeks, suggesting borderline statistical significance). At study entry, the PMA favored the NIDCAP group by 0.18 weeks offsetting the findings in PMA at discharge. There was moderate heterogeneity for both of these outcomes, with the same 2 clear outliers identified for both outcomes with mean differences in length of hospitalization of 43 and 44 days in the NIDCAP versus the control group and mean difference of 6 and 5 weeks in PMA [Als CHO 2003 (30) and McAnulty 2009 (14)] (Figs 5, 6). In sensitivity analyses (post-hoc analyses) excluding these 2 studies, statistical significance disappeared for both length of hospitalization and PMA at discharge and there was less in-between study heterogeneity making the findings more robust. Maguire and colleagues commenced NIDCAP within 48 hours of birth and included weekly behavioral interventions and found no significant differences in respiratory support, days of intensive care, growth or neuromotor development at term PMA, nor on growth, cognitive, psychomotor, and neurodevelopment at 1 and 2 years in infants born at < 32 weeks' PMA (13, 36). Our findings are in agreement with this well conducted study.
We disagree with Dr Haumont et al who state: "There is little need of randomized controlled trials (RCT) to evaluate the importance of: pain and stress management, protection of sleep, effects of bright light and noise, hemodynamic changes related to handling, positioning, skin-to-skin, breastfeeding, parental presence and supportive patient-caregiver relationship. All these aspects have been addressed and studied" (3). The Cochrane review on 'Sucrose for analgesia in newborn infants undergoing painful procedures' includes 57 studies enrolling 4730 infants, but concludes that "Additional research is needed to determine the minimally effective dose of sucrose during a single painful procedure and the effect of repeated sucrose administration on immediate (pain intensity) and long- term (neurodevelopmental) outcomes" (37). The Cochrane review on the effects of cycled lighting in 469 infants reports that trends for many outcomes favored cycled light compared with near darkness, and for cycled light compared with continuous bright light, but the intervention requires further trials (38). The upcoming review on "Noise reduction management in the neonatal intensive care unit for preterm or very low birth weight infants" will likely only include two small trials (39). So yes, these interventions have been studied, but further RCTs are needed, the results of which should inform developmental care practices.
We strongly advocate health-care providers in the 'European Association of Developmental Care' to consider our systematic review and provide interpretations of our findings with representatives of the parent initiated 'Association for Developmental Care' (3). We advise health-care providers and researchers in Europe, Japan and worldwide to consider our findings before deciding which developmental care interventions to introduce or to study further. We recommend that providers of any innovative hospital-based developmentally sensitive intervention for preterm infants take into account our findings using critical appraisal skills. Such interventions should start at birth in the resuscitation area, where the sensory input (stress) to the immature brain is enormous (9).
Nursing researchers have identified five categories or 'core measure sets' to represent the first step in operationalizing evidence-based developmental care (40). The 'core measures' are protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), family-centered care and the healing environment. We recommend that large well-designed, conducted and timely reported RCTs be undertaken in the preterm population of various combinations of these 'core measures' starting in the resuscitation area and using well-defined long-term clinical and neurodevelopmental outcomes (the composite of death or major sensorineural disability at 18 months corrected age or later in childhood) as the main end-points. We encourage consumers of neonatal health care or their ombudsmen to take part in setting the agenda and defining important outcomes for such research (8,16).
Systematic reviews of the literature serve as good examples of knowledge management, when defined as "making proper use of the sum of what is known" (32). We stand by our conclusions that "Because we were not able to identify any clear benefits of NIDCAP for long-term neurodevelopmental outcomes, nor for any short-term medical outcomes, we cannot recommend the implementation of NIDCAP in its present form as standard care in preterm infants" (1).
References 1. Ohlsson A, Jacobs SE. NIDCAP: A systematic review and meta-analyses of randomized controlled trials. Pediatrics. 2013;131(3):e881-893. 2. Als H. Re: Ohlsson and Jacobs, NIDCAP: A systematic review and meta- analyses. E-Letter to the Editor. Pediatrics published on line March 18, 2013. 3. Haumont, D, Amiel-Tison C, Casper C, et al. NIDCAP and developmental care: an European perspective. E-Letter to the editor. Pediatrics published on line March 14, 2013. 4. Lawhon g, Als H, Alberts JR, et al. NIDCAP Federation International response. E-Letter to the Editor. Pediatrics published on line March 12, 2013. 5. Nishida H. From the Japan Association of Research on Developmental Care. E-Letter to the Editor. Pediatrics published on line March 5, 2013. 6. Jacobs SE, Sokol J, Ohlsson A. The Newborn Individualized Developmental Care and Assessment Program is not supported by meta-analyses of the data [published correction appears in J Pediatr 2002;141:451-452]. J Pediatr. 2002;140(6):699-706. 7. Evidence Updates (http://plus.mcmaster.ca/EvidenceUpdates/). Accessed April 20, 2013. 8. Ohlsson A, Jacobs SE. Meta-regression can indicate if further NIDCAP studies are justified [in Swedish]. L?kartidningen. 2007;104(3):134-137. 9. Ohlsson A. NIDCAP: New controversial evidence for its effectiveness. Pediatrics. 2009;124(4):1213-1215. 10. Als H, Lawhon G, Brown E, et al. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: Neonatal intensive care unit and developmental outcome. Pediatrics 1986;78(6);1123-1132. 11. Buehler DM, Als H, Duffy FH, McAnulty GB, Liederman J. Effectiveness of individualized developmental care for low-risk preterm infants: behavioral and electrophysiologic evidence. Pediatrics 1995;96(5 Pt 1)923- 932. 12. Als H, Duffy FH, McAnulty GB, et al. Early experience alters brain function and structure. Pediatrics. 2004;113(4):846-857. 13. Maguire CM, Walther FJ, Sprij AJ, et al. Effects of individualized developmental care in a randomized trial of preterm infants < 32 weeks. Pediatrics 2009;124(4):1021-1030. 14. McAnulty G, Duffy F, Butler S, et al. Individualized developmental care for a large sample of very preterm infants: health, neurobehaviour and neurophysiology. Acta Paediatr. 2009;98(12):1920-1926. 15. Prechtl HFR. The neurological examination of the full-term infant: a manual for clinical use. 2nd ed. Clinics in Developmental Medicine, No 63, Philadelphia, PA: Lippincott, 1977. 16. Ohlsson A. Randomized controlled trials and systematic reviews: a foundation for evidence-based perinatal medicine. Acta Paediatr. 1996;85(6):647-655. 17. Schmidt B, Roberts RS, Davis P, et al. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007;357(19):1893-1902. 18. Jacobs SE, Morley CJ, Inder TE, et al. Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011;165(8):692-700. 19. Garland SM, Tobin JM, Pirotta M, et al. The ProPrems trial: investigating the effects of probiotics on late onset sepsis in very preterm infants. BMC Infect Dis 2011;11: 210. 20. Jacobs SE, Berg M, Hunt R, et al. Cooling for newborns with hypoxic ischaemic encephalopathy. Cochrane Database Syst Rev 2013 Jan 31;1:CD003311. 21. Ohlsson A, Walia R, Shah SS. Ibuprofen for the treatment of patent ductus arteriosus in preterm and/or low birth weight infants. Cochrane Database Syst Rev 2013 Apr 30;4:CD003481 22. American Academy of Pediatrics (the Committee on Fetus and Newborn; Committee on Drugs; Section on Anesthesiology; and Section on Surgery), Canadian Paediatric Society (the Fetus and Newborn Committee). Prevention and management of pain and stress in the newborn infant. Pediatrics 2000;105(2):454- 23. American Academy of Pediatrics (the Committee on Fetus and Newborn; Committee on Drugs; Section on Anesthesiology; and Section on Surgery), Canadian Paediatric Society (the Fetus and Newborn Committee). Prevention and management of pain and stress in the newborn infant. Paediatr Child Health 2000;5:31-47. 24. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org 25. Fowlie PW, Davis PG, McGuire W. Prophylactic intravenous indomethacin for preventing mortality and morbidity in preterm infants. Cochrane Database Syst Rev 2010 Jul 7;7:CD000174. 26. Lacy JB, Ohlsson A. Behavioral outcomes of environmental or care- giving hospital based interventions for preterm infants: a critical overview. Acta Paediatr. 1993;82(4):408-415 27. Westrup B, B?hm B, Lagercrantz H,Stjernqvist K. Preschool outcome in children born very prematurely and cared for according to the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). Acta Paediatr. 2004;93(4): 498-507. 28. McAnulty GB, Duffy FH, Butler SC, Bernstein JH, Zurakowski D, Als H. Effects of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) at age 8 years: preliminary data. Clin Pediatr (Phila). 2010;49(3):258-270. 29. McAnulty G, Duffy FH, Kosta S, et al. School-age effects of the newborn individualized developmental care and assessment program for preterm infants with intrauterine growth restriction: preliminary findings. BMC Pediatr 2013 Feb 19;13:25. 30. Als H, Gilkerson L, Duffy FH, et al. A three-center, randomized, controlled trial of individualized developmental care for very low birth weight preterm infants: medical, neurodevelopmental, parenting, and caregiving effects. J Dev Behav Pediatr 2003;24(6)399-408. Erratum in: J Dev Behav Pediatr 2004;25:224-225. 31. Review Manager (RevMan) [Computer program]. Copenhagan: The Nordic Cochrane Centre. The Cochrane Collaboration, 2011. 32. Ohlsson A. Knowledge translation and evidence-based perinatal/neonatal health care. Neonatal Netw 2002;21(5):69-74. 33. Als H, Duffy FH, McAnulty GB, et al. Is the newborn individualized developmental care and assessment program (NIDCAP) effective for preterm infants with intrauterine growth restriction? J Perinatol 2011;31(2)130- 136. 34. Als H, Duffy FH, McAnulty G, et al. NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol 2012;32(10):797-803 35. Als H, Butler S, Kosta S, McAnulty G. The assessment of preterm infants behavior (APIB): Furthering the understanding and measurement of neurodevelopmental competence in preterm and full-term infants. Ment Retard Dev Disabil Res Rev 2005;11(1):94-102. 36. Maguire CM, Walther FJ, van Zwieten PHT, et al. Follow-up outcomes at 1 and 2 years of infants born less than 32 weeks after newborn individualized developmental care and assessment program. Pediatrics 2009;123(4):1081-1087. 37. Stevens B, Yamada J, Lee GY, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev 2013 Jan 31;1:CD001069. 38. Morag I, Ohlsson A. Cycled light in the intensive care unit for preterm and low birth weight infants. Cochrane Database Syst Rev. 2011 Jan 19;(1):CD006982. 39. Almadhoob A, Ohlsson A. Noise reduction management in the neonatal intensive care unit for preterm or very low birthweight infants [Protocol]. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD010333. 40. Coughlin M, Gibbins S, Hoats S. Core measures for developmentally supportive care in neonatal intensive care units: theory, precedence and practice. J Adv Nurs 2009;65(10):2239-2248.
Arne Ohlsson, MD, MSc, FRCPC, FAAP and Susan E. Jacobs, MBBS, MD, FRACP
Conflict of Interest:
None declared
Response to NIDCAP Meta-analyses
This letter refers to the recent publication by Ohlsson and Jacobs regarding NIDCAP. Statements within the review show a misunderstanding and thus misrepresentation of NIDCAP, making the review questionable.
The authors state NIDCAP requires use of the APIB to assess for 1 hour before, during, and after caregiving. The NIDCAP uses an observational developmental assessment, not the APIB which is a hands-on assessment. The time required depends on variation in the individual infant's behavior and in the caregiving or procedure observed. The NIDCAP observation includes assessment of the neonate's autonomic, motor, state, and self- regulation capabilities, valuable knowledge for assessment of development. Information learned from a NIDCAP assessment is then incorporated into the individual infant's care planning to support their development within the context of their family. These recommendations for care are not then generalized, as stated in the review, but are always specific for an individual infant's status.
The review states 2 NIDCAP trials were not included because they tested NIDCAP during stressful procedures. That, however, is what NIDCAP methodology supports: observation of baseline behavior before, during care/procedures, and after to identify the individual infant's current capability to regain balance on their own or identify the need for support by the professional or parent caregiver resulting in strategies to adjust caregiving and environmental experience and assist this specific infant to achieve and maintain medical and developmental balance.
It would be enough to have inaccuracies of foundational methodology to question the review, however the inaccuracies and also inconsistencies continue. Another example of many is the stated primary outcomes of death or free of disability at 18 months which have never been target outcomes of NIDCAP research. The authors, however, evaluate whether NIDCAP studies meet these targets. The authors disregard brain imaging studies evaluated by blinded reviewers for not being meaningful outcomes.
NIDCAP has no side effects, unlike many other aspects of neonatal care. No NIDCAP studies have demonstrated harm to the patient. NIDCAP draws from numerous scientific disciplines for its foundation. This fosters viewing the patient as an integrated complex human being rather than the sum of separate physiologic systems. Professionals without such a comprehensive understanding of integrated human development often have difficulty viewing neonatal patients as people whose developmental pathways change because of experience, including how care is provided in the NICU. An incomplete appreciation of human complexity leads to missed opportunities to guide comprehensive development along the most optimal path while simultaneously providing necessary care. Respecting the patient as a multi-faceted person and placing them at the center of healthcare may not be flashy, but it is the right thing to do.
Diane Ballweg, MSN, RN, CCNS, RNC-NIC Certified Clinical Nurse Specialist Mayo Clinic
Conflict of Interest:
None declared
Statement from parent organizations
We refer to the recent article "NIDCAP: a Systemic Review and Meta- Analyses of Randomized Controlled Trials" by Arne Ohlsson and Susan Jacobs which appeared in Volume 131, Number 3 of the Pediatrics journal.
We note some of the impressive results of NIDCAP in Olhsson and Jacobs (2013), where the NDICAP program showed significant positive outcomes for premature infants, including:
* Reduced Hospitalisation (Table 3) * Earlier (younger post-menstrual age) hospital discharges (Table 3) * Enhanced weight gain (Table 4) * Improved neurological markers, seen in both EEG and MRI * Improvements on several standard assessment tools, including the Bayley MDI, Baylet PDI, and APIB (Table 2 and Figure 3)
Why does the meta-analysis ignore these substantive, impressive and clinically important findings in the report? We note that the set criteria for measuring the success of the NIDCAP program i.e. "the composite of death or major sensorineural disability at 18 months" as well as secondary, short-term outcomes such as "in hospital deaths, chronic lung disease... necrotizing enterocolitis, intraventricular haemorrhage..." are in sharp contrast to the goals of NIDCAP, set by Heidelise Als over 30 years ago. " NIDCAP's goal is to prevent unexpected sensory overload and pain, and enhance strength and competence" of infants born prematurely (Als et al., 2004). The NIDCAP program combines observation, assessment and nursery interactions by providing opportunities for individualized attention to the infant to guide holding, positioning and care, recommend environmental adjustments to ensure maximum stability, relaxation and emerging developmental progressions , provide parental support and promote parental involvement and provide nursery staff training. By appropriately evaluating NIDCAP based on the goals set for the program, the results are excellent.
Olhsson and Jacobs (2013) have overlooked the neurodevelopmental data and evidence based principles of the NIDCAP program, especially in the areas involving sensory development and the resulting consequences when the infant receives stimulations too early, the relationship between stress hormones and autonomic development, regulation of sleep and attentional states and the development of parent-infant interactions. Among the research questions identified by Als et al (2004) and omitted from Ohlsson and Jacobs (2013) are: "neurophysiological and brain structural outcomes: "effects on parents" and "effects on staff and systems".
We represent a multitude of parents across Europe who have experienced the benefits of the NIDCAP program. Since its inception NICU practice has changed, beneficial environmental features have been introduced in neonatal nurseries, parental involvement has been enhanced and the experiences and developmental outcomes for premature babies have improved dramatically.
Conflict of Interest:
None declared
Response :NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials
This letter is in response to the Ohlsson and Jacobs's article (2013), entitled "NIDCAP: A Systematic Review and Meta- analysis of Randomized Controlled Trials". The article is the fourth by these authors critically reviewing the Newborn Individualized Care and Assessment Program for preterm and fragile infants and their families. The authors chose to assess the effectiveness of NIDCAP comparing neurodevelopmental and medical outcome however their analyses was limited to major sensorineural disability, death or severe medical conditions. It is of note that their conclusive remarks do not recommend NIDCAP as a standard of care however the article provides evidence supporting the effectiveness of NIDCAP including but not limited to reduced length of hospitalization, improved daily weight gain, and better APIB (Assessment of Preterm Infants' Behavior) and Neurological Examination of the Fullterm Newborn scores (Prechtl) at 2 weeks CA. It is also unfortunate that the authors excluded positive results demonstrated in neuroimaging and neurophysiological outcome studies.
We feel it is important to comment on this article from the perspective of NIDCAP trained therapists. As neonatal physical therapists, we assess and subsequently provide intervention to infants in NICU settings. Additionally, we collaborate with parents to support their needs to engage with and care for their infants (Byrne & Gerber 2013). Neonatal therapy requires advanced training competencies, not taught in entry level physical therapy curriculum, to safely and effectively meet the neurodevelopmental and musculoskeletal needs of physiologically unstable infants. Therapists trained in the NIDCAP approach develop a unique skill set that is sensitive to the interplay of an infant's autonomic, motor, state-organizational, attention-interaction, and regulatory subsystems with each other and with the environment (Sweeney et al 2010). This allows for competent practice in the NICU as outlined in "Neonatal Physical Therapy. Part II; Practice Frameworks and Evidence Based Guidelines (Sweeney et al, 2010). Although NIDCAP observations and planning is one of few hands-off assessments used by therapists it is a vital component as it provides information on stressful effects of caregiving and knowledge of infant sensorimotor behavior in the NICU environment. This information is an important addition to other evaluation tools as therapists develop plans of care to foster individualized development and ensure readiness to participate in movement therapy.
This article is confusing in setting up false purposes, conclusions contradicting information provided, dismissing studies with neurophysiological outcomes and discounting benefits of the NIDCAP approach without apparent familiarity with the NIDCAP approach. With these limitations, it does not lend any value to the discussion of best- practices in the NICU. The difference with NIDCAP is also that it is not a technique that can become obsolete, old fashioned etc...but a way of being, a way of linking caregivers, families, babies to a common objective, and that change is on its way in many many units thanks to NIDCAP. One cannot stop that kind of change with words.
Byrne, E , Garber,J. (2013). Physical Therapy Intervention in the Neonatal Intensive Care Unit. Physical & Occupational Therapy in Pediatrics.,33, (1): 75- 110.
Byrne, E , Campbell. (2013). Physical Therapy Observation and Assessment in in the Neonatal Intensive Care Unit. Physical & Occupational Therapy in Pediatrics.33, (1): 39- 74.
Sweeney, J.K., Heriza, C. B., Blanchard,Y. & Dusing, S. C. (2010). Neonatal Physical Therapy. Part II: Practice frameworks and evidence-based practice guidelines. Pediatric Physical Therapy, 22,2-11.
Marie Reilly PT, PhD Developmental Team WakeMed, Raleigh, NC Adjunct Associate Professor Division of Physical Therapy The University of North Carolina, Chapel Hill, NC
Natascia Bertoncelli PT, NIDCAP Trainer
NICU - Italian Modena NIDCAP Training Centre - Italy
Jennie Schooling, MCSP, NIDCAP practitioner
John Chappel,P.T. , MA. NY and NJ licensed
Arlene J. Verno, PT, DPT NICU Developmental Specialist Virtua Hospital, Voorhees Division Voorhees, NJ
C. R?mont - PT- Belgium
AnnMarie Elmore MSPT, ITSP, MA Apex, NC
Conflict of Interest:
None declared
Re: Ohlsson and Jacobs, NIDCAP: A Systematic Review and Meta-analyses
Letter to the Editor Re: Ohlsson, A. and S.E. Jacobs, NIDCAP: A Systematic Review and Meta- Analyses
This is the fourth NIDCAP meta-analysis by Ohlsson and Jacobs. As in the prior analyses the authors' abstract and conclusions are not supported by the authors' reported findings.
Issues of concern:
1. The authors confuse key-methodologies: NIDCAP [1] and APIB [2, 3] are two different instruments. NIDCAP entails naturalistic observations of infants at rest and during caregiver interaction; the APIB is an interactive formal neurobehavioral newborn assessment. The Prechtl Neurological Assessment of the Fullterm Newborn Infant [4] and Prechtl's General Movement Assessment [5] are also two very different assessments. The authors throughout confuse these methodologies.
2. The authors again combine studies reporting on outcome measures logically inconsistent for the samples considered: E.g. NIDCAP intervention for low-risk infants (preterms 28 - 33 weeks gestational age, never ventilated, etc), cannot yield shorter durations of intubation, less CLD and IVH because the sample was chosen to exclude infants with these issues. Only NIDCAP studies involving high-risk ventilated infants can address these issues. Disregard of this logic yields meaningless results and amounts to mixing 'apples and oranges'.
3. Ohlsson and Jacobs describe NIDCAP's goal as reduction of mortality and severe disabilities, such as CP, blindness and deafness. This goal has never been proposed by any NIDCAP-investigator. NIDCAP was developed to improve the quality of neurodevelopmental functioning of viable infants cared for in Newborn Intensive and Special Care Nurseries.
And, indeed, Ohlsson and Jacobs document the benefits that NIDCAP trials have reported. All are clinically relevant and developmentally meaningful. The authors list as significant benefits:
a. Health and hospital benefits (Table 3)
1) Significantly reduced length of hospitalization 2) Significantly younger (post-menstrual age) at discharge
b. Growth benefits (Table 4): Significantly improved daily weight gain
c. Significantly improved Bayley MDI (Mental Developmental Index) scores at 9 months CA (Table 2 and Figure 3)
d. Significantly improved Bayley PDI (Psychomotor Developmental Index) scores at 9 months CA (Table 2, Figure 3)
e. Significantly improved APIB (Assessment of Preterm Infants' Behavior) and Prechtl scores at 2 weeks CA
f. Significantly improved EEG and MRI findings, (which the authors choose not to include 'as they are surrogate biomarkers for long-term neurodevelopment').
Despite these numerous significant benefits Ohlsson and Jacobs conclude: 'Because we were not able to identify any clear benefits of NIDCAP neither for long-term neurodevelopmental nor for short term medical outcomes, we cannot recommend the implementation of NIDCAP in its present form as standard care in preterm infants'.
These methodological issues alone require the scientific community to disregard this report and bring into question it's publication in a journal of this stature.
NIDCAP requires readiness to embrace each infant as a person who communicates what stresses the infant and what makes the infant comfortable. NIDCAP also requires readiness to embrace the parents as the infant's key providers and advocates. Families and NICU professionals in many countries feel that NIDCAP is the most humane and comprehensive model of care available and is the infants and the families' right. And Ohlsson and Jacobs prove NIDCAP's scientific validity.
Heidelise Als, PhD 11 March 2013
1. Als, H., Program Guide - Newborn Individualized Developmental Care and Assessment Program (NIDCAP): An Education and Training Program for Health Care Professionals1986 rev 2011, Boston: Copyright, NIDCAP Federation International
2. Als, H., et al., Manual for the assessment of preterm infants' behavior (APIB), in Theory and Research in Behavioral Pediatrics, H.E. Fitzgerald, B.M. Lester, and M.W. Yogman, Editors. 1982, Plenum Press: New York. p. 65-132.
3. Als, H., et al., Towards a research instrument for the assessment of preterm infants' behavior, in Theory and Research in Behavioral Pediatrics, H.E. Fitzgerald, B.M. Lester, and M.W. Yogman, Editors. 1982, Plenum Press: New York. p. 35-63.
4. Prechtl, H.F.R., The Neurological Examination of the Full-term Infant: A manual for clinical use. 2nd edition ed. Clinics in Developmental Medicine, No. 631977, Philadelphia: Lippincott.
5. Einspieler, C. and H.F. Prechtl, Prechtl's assessment of general movements: a diagnostic tool for the functional assessment of the young nervous system. Ment. Retard. Dev. Disabil. Res. Rev., 2005. 11(1): p. 61- 67.
Conflict of Interest:
I am the originator of the NIDCAP approach to newborn care, and the founder and former President of the NIDCAP Federation International, a non-profit organization, which assures the quality and is the certifying agency of international training in the NIDCAP approach for advanced professionals in the field of newborn care in hospital settings.
Occupational Therapists respond
March 14, 2013
Dear Editor,
We represent an international group of clinical, academic and research-based occupational therapists with decades of collective experience working in newborn intensive care. As advocates for implementation of high quality evidence-based practice, we were disappointed in Ohlsson & Jacobs 2013 summary interpretation of their most recent meta-analysis of the NIDCAP approach. Shrier et al(1) urge caution with meta-analysis, stating "the interpretation of the data remains a highly subjective process even among reviewers with extensive experience conducting meta-analyses" (1, Discussion section, para.1). They propose that discrepancies in interpretation can "reflect a difference in personal values, resistance to change, and other personal preferences" (1, Background section, para. 3). We prefer not to speculate on the motivations of Ohlsson & Jacobs, yet dismissing an entire body of evidence based on a limited and often-subjective statistical approach seems misguided.
Over the past 30 years the role of the occupational therapist with newborns and families has been substantially informed by NIDCAP theory, research and practice(2). Rigorous and methodical studies of NIDCAP have improved our understanding of infant brain development, and the iatrogenic damage that can be caused by well-intended, but unaware care providers in the NICU. The mindful care that Ohlsson & Jacobs refer to as "rational and intuitive" did not exist before NIDCAP.
Ohlsson & Jacobs outcome measure of death or major disability is not congruent with Als' consistently stated purpose: "NIDCAP emphasizes the behavioral individuality of each infant. It seeks to diminish the infant's experiences of stress and to enhance the infant's strengths."(3, p. 401). Also, Ohlsson and Jacobs clearly describe a number of benefits experienced by infants, yet repeatedly dismiss them as not "clinically important", and parental outcomes are not addressed. Data from this meta- analysis, and other research, show that infants in newborn intensive care benefit directly from NIDCAP, as do parents who also experience significant stress which is reduced by NIDCAP intervention(3). We wonder if similar benefits were reported by a medication or technology whether the interpretation would be the same.
Finally, Ohlsson & Jacobs rely heavily on findings reported by Maguire(4), yet shortcomings of those studies have been detailed(5). Of concern, they misrepresent outcome Prechtl scores from Maguire(4) who stated: "We found no significant difference in our study, in which neurobehavioral outcomes, according to the method described by Prechtl, were defined as definitely abnormal, mildly abnormal, or normal." (4, p. 1026). Ohlsson & Jacobs imply otherwise; this example calls into question the objectivity of the entire analysis.
Few medical devices or medications in the NICU have been subjected to as complete and thorough investigation for safety and effectiveness as has NIDCAP. Three decades of study have shown that NIDCAP "first, does no harm" and that it is beneficial. Therefore, we would challenge your readers to remain accurately informed regarding this safe, cost-effective and humane approach that seeks to improve the immediate and long term outcomes for our most vulnerable infants and their families. Sincerely,
Laurie Mouradian, ScD, ATR, OTR/L Program Director & Associate Professor School of Occupational Therapy Husson University Bangor, ME, USA
Virginia L. Laadt, PhD, OTR Former Director, Developmental Care Program University of New Mexico Health Sciences Center, Department of Pediatrics, Division of Neonatology Albuquerque, NM, USA
Constance Eggert, OTR, MSPT Neonatal Developmental Therapy Specialist, Developmental Care Associates LLC Denver, Colorado, USA
Helen Hardy, BA DipOT Occupational Therapist PO Box 109 Westmead NSW 2145, Australia
Beverley Hicks, BSc(HOT) Lead for Developmental Care Imperial College Healthcare NHS Trust London, UK
Jennifer J Hofherr, OTR/L, C/NDT Developmental Specialist, NICU & NIDCAP Trainer University of Illinois Hospital and Health Systems Dissemination Specialist and Trainer, Fussy Baby Network Erikson Institute Chicago, Illinois, USA
Carol Matthews, OTR/L NIDCAP professional Anchorage, Alaska USA
Debra Paul, BS, OTR Program Manager, Department of Occupational Therapy, Rehabilitation Medicine NIDCAP Professional Children's Hospital Colorado Aurora, Colorado, USA
References: 1. Shrier, I., Boivin, J-F., Platt, R.W., Steele, R.J., Brophy, J.M., Carnevale, F., Rossignol, M. The interpretation of systematic reviews with meta-analysis: an objective or subjective process? BMC Medical Infomatics and Decision Making. 2008; 8(19). doi 10.1186/1472-6947-8-19
2. American Occupational Therapy Association, Commission on Practice. Specialized knowledge and skills for occupational therapy practice in the neonatal intensive care unit. American Journal of Occupational Therapy. 2006; 60: 659-668. Reviewed 2010. http://www.aota.org/Practitioners/Official/Skills/39462.aspx?FT=.pdf. Accessed March 10, 2013.
3. Als, H., Gilkerson, L., Duffy, F.H., McAnulty, G., Buehler, D. VandenBerg, K., Sweet, N....Jones, K. A three-center, randomized, controlled trial of individualized developmental dare for very low birth weight preterm infants: medical, neurodevelopmental, parenting, and caregiving effects. Journal of Developmental and Behavioral Pediatrics. 2003; 24: 399-408.
4. Maguire, C., Walther, F., Sprij, A. J., Le Cessie, S., Wit, J.M. & Veen, S. Effects of individualized developmental care in a randomized trial of preterm infants <32 Weeks. Pediatrics. 2009; 124:1021-1030. doi: 10.1542/peds.2008-1881.
5. Als, H.: NIDCAP: Testing the effectiveness of a relationship-based comprehensive intervention. Pediatrics. 2009;124:1208-1210. doi: 10.1542/peds.2009-1646.
Conflict of Interest:
None declared
NIDCAP and Developmental Care: an European perspective
The systematic review from Ohlsson and Jacobs on NIDCAP approach concluded that there is no evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcome (1). Despite their conclusion "Because NIDCAP was not effective in reducing adverse outcomes, performing cost-effectiveness analyses became redundant", they report that NIDCAP is associated with a better daily weight gain, a shorter length of hospitalization and an increase in BSID at 9 months. Developmental care and environmental strategies emerged in reaction to the background of the potential harmful effects of traditional NICU settings. When neonatal intensive care started in the sixties, its priority was survival as in adult intensive care. It took some time before the effects on the vulnerable growing preterm brain from the stressful environment and mother -infant separation were recognized. Many NICUs still consider technical aspects of care as a priority and parents as visitors. In Europe most elements of Early Developmental Care (EDC) are routinely applied in Scandinavian countries, however an increasing number of nurseries around Europe are changing their practices. NIDCAP as an entity is difficult to study because it embraces a range of interventions and behavioral changes, and the level of intervention is not standardized. Conventional randomized trial methodologies are very difficult to use with such global intervention strategies and it is thus highly difficult to attempt interpret to use them. There is litlle need of randomized controlled trials (RCT) to evaluate the importance of: pain and stress management, protection of sleep, effects of bright light and noise, hemodynamic changes related to handling, positioning, skin-to-skin, breastfeeding, parental presence and supportive patient-caregiver relationship. All these aspects have been addressed and studied (2). Anyway these are markers of respect for the baby. There is sufficient scientific evidence for the relevance of an adequate physical environment reducing overwhelming sensory stimulations, and increasing sensitive parent caregiving on brain development of preterm infants. NIDCAP addresses all these issues and is, today, probably the best defined and evaluated method for optimizing care allowing tuning in the baby's behavioural responses with parents as the primary caregivers. Rather than discouraging the promotion of NIDCAP and thus EDC, we should focus our interest on a large body of evidence from the neuroscience literature which clearly confirm the deleterious effects of NICU stress and highlight effects of early developmental care and parental intervention (4, 5). There is a need to engage in high quality research using techniques learnt from to the environmental enrichment literature in order to advance in the field. We academic neonatologists need to offer validated and affordable teaching programs to implement EDC. We have therefore created a European association for developmental care. The parent initiated European Foundation for the Care of Newborn Infants strongly supports a general implementation of NIDCAP and developmental care (EFCNI White Paper). The findings of the paper by Ohlsson & Jacobs could dissuade caregivers devoting all their energies making this important step to more neurodevelopmentally driven Nicus and to provide a high quality support for parent-infant interaction.
1. Ohlsson A, Jacobs SE. NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials. Pediatrics 2013; 131: 881-93
2. Haumont D (2011) Environment and early developmental care. In : Buonocore, G, Bracci R, Weindling M (eds ) Neonatology, a practical approach to neonatal management. Springer-Verlag, Italia, p 197
3. Sizun J, Westrup B (2004) Early developmental care for preterm neonates: a call for more research. Arch Dis Child Fetal Neonatal Ed. 89: F384-8
4. Smith GC, Gutovich J, Smyser C et al. (2011) Neonatal Intensive Care Unit stress is associated with brain development in preterm infants. Ann Neurol. 70 :541-9
5. Milgrom J, Newnham C, Anderson PJ et al. (2010) Early sensitivity training for parents of preterm infants: impact on the developing brain. Pediatr Res 67: 330-5
Conflict of Interest:
None declared
A nurse's perspective
As nurses working in Newborn Intensive Care, we are concerned about the publication; NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Analysis by Arne Ohlsson and Susan E. Jacobs as there are many disparities and inaccuracies within the article that individuals not familiar with the details of the NIDCAP work may overlook. The authors have misrepresented NIDCAP concepts and process throughout the paper. As clinicians who rely on evidence-based practice(EBP)in order to guide informed choices for professional practice, we believe it is unconscionable to publish a misleading article such as this. It puts the integrity of NIDCAP as well as EBP at risk.
The second sentence of the article reveals the authors' misinformation and misunderstanding as they confuse two very different assessment tools within the NIDCAP work, namely the NIDCAP Observation and the Assessment of Preterm Infants' Behavior (APIB) evaluation. Throughout the article they interchange the meaning of these two assessments. Furthermore, the authors mis-define NIDCAP as environmental modifications such as incubator covers and nesting. NIDCAP is defined as a "process to bring about a shift from protocol-based to strategic process thinking and from task-oriented to relationship-based care. The developmental approach to care sees infants as active collaborators of their own developmental trajectories, supported by the ongoing co-regulation process of infant and parent development", Als 1999.
The foundational component of NIDCAP that acknowledges the uniqueness and individuality of each infant and the infant's family supporting their developing relationship is lacking completely from the publication. The NIDCAP Naturalistic Behavioral Observation provides a format for the professional caregiver to observe the infant's behavior, create a written report for the health care team including the parent to better understand the infant's neurobehavioral agenda and goals with recommendation for the infant to achieve those goals. It provides a venue to enhance an understanding of the infant's experience and developing relationships. The NIDCAP work has continued to evolve from the initial publications to include systematic organization approaches to improving infant outcomes with topics such as reflection, parental competence and confidence as well as social-emotional component of the environment.(Gilkerson, Als 1995, Kleberg et al 2000, 2007, Browne and Talmi 2005)
We are requesting that the journal provide a comprehensive and accurate description of what the NIDCAP process is as well as an unbiased review of the NIDCAP research to date. As readers of Pediatrics, we appreciate your consideration of this request.
Als H (1999). Reading the premature infant. In Goldson E (ed.) Nurturing the Premature Infant: Developmental Interventions in the Neonatal Intensive Care Nursery. New York: Oxford University Press, 18-85.
Gilkerson L, Als H (1995). Role of reflective process in the implementation of developmentally supportive care in the newborn intensive care nursery. Infants and Young Children. 7, 20-28.
Kleberg A, Westrup B & Stjernqvist K (2000). Developmental outcome, child behaviour and motherchild interaction at 3 years of age following newborn individualized developmental care and intervention program (nidcap) intervention. Early Human Development. 60,123-135.
Kleberg A, Hellstr?m-Westas L & Widstr?m A-M (2007). Mothers' perception of newborn individualized developmental care and assessment program (nidcap) as compared to conventional care. Early Human Development. 83(6), 403-411.
Browne, JV & Talmi A (2005). Family-based intervention to enhance infant-parent relationships in the neonatal intensive care unit. Journal of Pediatric Psychology. 30(8),1-11.
Conflict of Interest:
None declared
NIDCAP Federation International Response
Ohlsson and Jacobs (2013) have again examined the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) and the research that represents its efficacy. Herein, the Board of Directors of the NIDCAP Federation International (NFI)1 deems their report an invalid and misleading evaluation of a well-established and demonstrably effective program.
In fact, they summarize an array of impressive results, most from RCTs - in which NIDCAP treatment of prematurely-born infants produced statistically significant effects (tables, figure and findings all from Ohlsson & Jacobs (2013), including: * Reduced hospitalization (Table 3) * Earlier (younger post-menstrual age) hospital discharges (Table 3) * Enhanced weight gain (Table 4) * Improved neurological markers, seen in both EEG and MRI * Improvements on several standard assessment tools, including the Bayley MDI, Bayley PDI, and APIB (Table 2 and Figure 3)
By applying inappropriate criteria to measure success, the authors manage to dismiss the substantive, impressive, and clinically-significant findings summarized in the report. Specifically the authors set the bar for "effectiveness of NIDCAP" in terms of "the composite of death or major sensorineural disability at 18 months" as well as secondary, short-term outcomes such as "in hospital deaths, chronic lung disease . . . necrotizing enterocolitis, intraventricular hemorrhage . . ." and the like. In contrast, NIDCAP is aimed at a different array of important targets. Heidelise Als, who designed and founded NIDCAP more than 30 years ago, states "NIDCAP's goal is to prevent unexpected sensory overload and pain, and enhance strength and competence" of infants born prematurely (Als, et al., 2004). Such pathways are guided by a combination of observation, assessment and nursery interactions. These guide regimes of holding, positioning and movement, environmental modification, parental involvement, and staff education that lead to enhanced developmental trajectories. This is where the bar for NIDCAP should be placed. These are the standards by which NIDCAP is evaluated appropriately with significant results in both medical and developmental parameters.
NIDCAP rests on a large body of neurodevelopmental data and evidence- based principles, particularly in areas involving sensory systems development, relations between stress hormones and autonomic development, regulation of infant sleep and attention states, and the emergence of parent-infant interactions. These core areas were overlooked or even ignored in the meta-analysis. As NIDCAP professionals representing a range of relevant disciplines, along with parents who have experienced the developmental challenges of prematurely born babies, we seek to understand how NIDCAP works and the parameters affecting each of its elements. Among the research questions explicitly identified by Als et al (2004) and ignored by Ohlsson and Jacobs (2013) are: "neurophysiological and brain structural outcomes", "effects on parents" and "effects on staff and systems". Perhaps Ohlsson and Jacobs' resistance to evaluating NIDCAP on relevant dimensions reflects their own resistance to systems change.
NIDCAP has already changed NICU practice, contributed to novel environmental features, enhanced parental involvement, and improved the experiences and developmental outcomes of premature babies worldwide. We look forward to continuing to enhance the future of infants and parents who experience intensive care.
Sincerely,
gretchen Lawhon, PhD, RN, FAAN President, Mid-Atlantic NIDCAP Center, Camden, NJ, US
James M. Helm, PhD Vice President for Administration, Carolina NIDCAP Training Center,?Raleigh, NC, US
Deborah Buehler, PhD, Vice President for Organizational Advancement and Secretary, West Coast NIDCAP & APIB Training Center, San Francisco, CA, US
Gloria McAnulty, PhD, Treasurer, National NIDCAP Training Center,?Boston, MA, US
Sandra Kosta, BA, Assistant Secretary/Assistant Treasurer, ?National NIDCAP Training Center, Boston, MA, US
Jeffrey R. Alberts, PhD,?Indiana University,?Bloomington, IN, US
Heidelise Als, PhD, Founder and Former President, National NIDCAP Training Center, Boston, MA, US
Silke Mader,?Family Representative, Karlsfeld, Germany
Mandy Daly, Dip.H Diet & Nutrition, ACII, DLDU, Family Representative, Dublin, Ireland
Jacques Sizun, MD,?French NIDCAP Center,?Brest, France
Kathleen VandenBerg, PhD,?West Coast NIDCAP & APIB Training Center,?San Francisco, CA, US
Inga Warren, Dip COT, MSc,?UK NIDCAP Training Centre at St. Mary's,?London, UK
References and Endnote Als, H., Duffy, F. H., McAnulty, G. B., Rivkin, M. J., Vajapeyam, S., Mulkern, R. V., . . . Eichenwald, E. C. (2004, April). Early Experience Alters Brain Function and Structure. Pediatrics, 113(4), 846-857. Ohlsson, A., & Jacobs, S. E. (2013, February 19). NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials. Pediatrics, 131(3), 881-893. doi:10.1542/peds.2012-2121
1. The NFI was incorporated in 2001 as not-for-profit membership organization that educates and supports NIDCAP professionals in newborn intensive care units (NICUs) around the world and has certified 21 NIDCAP Training Centers in 10 countries (with more underway).
Conflict of Interest:
all authors are the Members of the Board of Directors of NIDCAP Federation International
Knowledge Vs Information
I have read your publication of the meta-analysis on NIDCAP by Ohlsson and Jacobs and would like to make the following comments. It struck me that there is a difference between information and knowledge as one can have access and possession of vast amounts of information but in the absence of its veracity and truth lack knowledge of that information. Information and knowledge need to be distinguished and the two need to balance each other so as to provide a sound argument for any recommendation or conclusion. You may have information, supplied as data as seen unreflectively in the meta-analysis of the NIDCAP as an intervention. It is dangerous as it is misleading to use such information alone as the reader interprets tables and data to assist them in clinical decisions. Information without knowledge of its veracity and justification does not provide the full story and can lead to bias from the authors of the paper published in your journal. In this paper the authors appear to have a limited understanding of the intervention that they have so strongly criticised. NIDCAP is a practice intervention involving health professionals (not just nurses) and parents who read the infant's cues and provide an individualised care plan. It can vary in different contexts, be used in many ways including palliative care and is a humane approach to a toxic NICU environment. Perhaps the challenge for the authors is to consider alternative recommendations for measuring outcomes rather than trying to fit the intervention into their own criteria and making a blanket conclusion that lacks justification and support.
Conflict of Interest:
None declared
NIDCAP as a psychosocial intervention
Sir,
It is with great interest we have read the paper by Ohlsson and Jacobs(1). From our perspective, as neonatologists, it is difficult to understand that the authors did not find any evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcomes. In particular, while the results according to their meta-analyses are indicating significant advances in NIDCAP-based care. This is exemplied by improved Bayley PDI scores at 9 months as well as a reduced length of hosptalization overall. What is the motivation of Ohlsson and Jacobs? In their opinion is it just a matter of inclusion criteria or do we see a discrepancy in the attitude towards the preterm infant? It is our experience that the improvement in outcome is real. In our understanding, one standpoint is to trust on tools like Bailey scales of infant development, another to understand that NIDCAP is a long-term psychosocial intervention with both medical and psychosocial consequences. The NIDCAP system is intending to strengthen the bounding process between the preterm infant and its parents. The method is teaching families with preterm infants to view, intellectually and emotionally, their child as a fullworthy human being, albeit born too early to be able to communicate as full-term infants do. Parental attitudes of approaching their child in terms of basic human rights and respect are reinforced. To our knowledge, it is obvious that the NIDCAP system is more diversified and subtile then just measuring the outcome in matter of alive or dead. This is the reason for using more sophisticated tools like evaluating cerebral activity by EEG, by evaluating parent-infant interactions and bilateral social competence in the way Als(2,3) and others(4) have done over the last decades.
References:
1. Ohlsson A, Jacobs SE. NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials. Pediatrics. 2013; 131(3): 2881-93. doi: 1542/peds.2012-1221. Epub 2013 Feb 18
2. Als, H, Duffy, FH, McAnulty, GB et al.: Early experience alters brain function and structure. Pediatrics. 2004; 113(4): 846-57
3. Als H, Duffy, FH, McAnulty, GB et al.: NIDCAP improves brain function and structure in preterm infants with severe intrauterine growth restriction. J Perinatol. 2012; 32(10): 797-803. doi: 10.1038/jp.2011.201. Epub 2012 Feb 2
4. Kleberg A, Westrup B, Stjernqvist K: Developmental outcome, child behaviour and mother-child interaction at 3 years of age following Newborn Individualized Developmental Care and Assessment Program (NIDCAP) intervention. Early Hum Dev. 2000; 60(2): 123-35
Conflict of Interest:
None declared
Conceptually misleading
To the Editor,
Following the reading of the Review of NIDCAP work by Ohlsson and Jacobs the reader is left with a deep feeling of uneasiness. From the very first statements the authors confound and mix together two different types of preterm infant assessment, namely the NIDCAP (an essentially naturalistic, observational assessment) and the APIB (an assessment in which the examiner purposely elicits the infant's responses), thus conceptually misleading the reader and setting the ground for suspecting that several other statements in this review could be inaccurate as well.
One would hope and expect from a prestigious peer reviewed medical journal not to overlook this sort of inaccuracies, which pave the way to the concern that the authors may not have a deep understanding and insight on the matters they are reviewing.
The statistical tools might have been neatly used, yet the basic concepts and the whole purpose of the NIDCAP model for preterm infant care seem to have been regrettably mixed up.
Conflict of Interest:
None declared
Pediatric Psychologists' Perspective
To the editor:
A careful reading of the Ohlsson and Jacobs article published online on February 18, 2013 brings to light concerns regarding the authors' interpretations of their analyses, and inferences that are inconsistent with the collective evidence base. As pediatric psychologists, each with over 26 years of experience working in a NICU and assessing infants in follow-up clinics, we will focus our comments primarily on the developmental outcome results. We expect others will comment on the selection of outcome variables not appropriate for the research reviewed (i.e. death), methodological flaws, and dismissal of outcomes such as shortened length of stay, so important to both families and payors.
The authors dismiss as "essentially meaningless" the consistent statistically and yes, clinically significant differences in the 9 month Bayley MDI data and in several other time periods. The subtle aspects of behavioral organization in infancy, for which there are few if any reliable formal assessment instruments, do appear to us as experienced neurodevelopmental evaluators to influence results in the assessment of infants and toddlers, especially in the pre-verbal period. To ignore the repeated findings of better scores at nine months, which may well indicate better behavioral organization and/or executive function in these infants, is to potentially miss valuable information about real differences in developmentally important aspects of function. These results are consistent with the findings that the authors acknowledge have been found in the results of Assessment of Preterm Infant Behavior assessments, also sensitive indicators of behavioral organization. It is unclear why such findings are reported in the article, and then their significance ignored in a population of children for whom there is much data suggesting that deficits in behavioral organization is a frequent outcome.
Another clearly incorrect point in the summary of the article, the statement that NIDCAP requires "regular APIB assessments" (no, it requires regular NIDCAP assessments, which are quite different from APIB assessments) is concerning in terms of its indication of a lack of understanding of the actual process of NIDCAP implementation. The description of NIDCAP as "resource-consuming, labor-intensive, and expensive" without any comparison to other care practices, cost data, or analysis of the savings generated by the shortened length of stay reported elsewhere in the article is particularly puzzling in a review that states its intent to examine the evidence.
Overall, the tone of the article and the points that the authors emphasize suggest that there is very little positive about the NIDCAP approach that the authors find relevant, while their reference to specific practices (covering incubators, cycled lighting) suggests that they fail to grasp the complex, integrated, individualized and humane approach that is at the core of the NIDCAP approach to the care of premature infants. While lively debate about best practice is essential for progress in any aspect of care, it is hard to see how an article with these and other methodologic flaws contributes to the debate.
Sincerely,
Melissa R. Johnson, Ph.D. Pediatric Psychologist Division of Neonatology, WakeMed, Raleigh, NC Adjunct Associate Professor, Departments of Pediatrics and Psychiatry, UNC -Chapel Hill School of Medicine
Joy Voyles Browne, Ph.D., PCNS-BC, IMH-E Pediatric Psychologist Clinical Professor of Pediatrics and Psychiatry University of Colorado Anschutz Medical Campus Aurora, Colorado Professor Queen's University School of Nursing and Midwifery Belfast, Northern Ireland
Conflict of Interest:
None declared
Re: NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials. Ohlsson and Jacobs. Originally published online February 18, 2013. DOI: 10.1542/peds.2012-2121
Dear editor The Synactive theory as developed and described by Als (1982) are used as framework for neurodevelopmental supportive care interventions in the South African contexts. Although though NIDCAP in this context are not implemented as described and suggested by Als and colleagues due to resource constraints, the clinical benefits of developmental supportive care are still evident; even when only selected components of the program are implemented.
Ohlsson and Jacobs highlighted benefits of NIDCAP, such as 'statistically significant decrease in length of hospitalization' as well as the number of days of supplemental oxygen, days on assisted ventilation, a daily weight gain of 1.5g, improved maturity resulting in earlier discharge from the hospital and improved neurodevelopmental outcome at nine months. These benefits support significant cost savings, which is of extreme benefit to a resource restricted country with a high prematurity rate (up to 25%), such as South Africa. It should be noted that these benefits are evident even when only selected interventions are implemented. If individual components have such a notable impact, how much more can be anticipated when the full spectrum is available.
NIDCAP requires no equipment or medications and in addition the education of staff and parents to be able to read and be attuned the newborn infant (based on the NIDCAP framework) has been successful in the resource restricted context of South Africa leading to improved short-term outcomes for the preterm infant population. Not even mentioned or explored is the job satisfaction for very overworked staff and the increased confidence of parents regarding their parenting skills of their infants in resource challenged and potentially harmful settings.
The review itself does however not seem very trustworthy, since Ohlsson and Jacobs stated various benefits of NIDCAP in their review article supported by their own previous reviews, but then conclude that NIDCAP has no short-term benefits and based on this 'lack of benefits' concluded that cost-effectiveness analysis became redundant. In my opinion the benefits mentioned will surely effect the cost of care and further prevent possible complications such as contracting nosocomial infection resulting in an increase in cost for hospitalisation and medical treatment - therefore a sure cost saving in any country.
Further challenging the trustworthiness of the review is the fact that the abstract and conclusions are not supported by the discussion of results as stated above. The authors seem bias towards inclusion criteria for the current review with the aim to support their view - a common threat of meta-analysis. This is evident in their exclusion of certain studies such as neurophysiological or neuroimaging studies based on their opinion that these are surrogate. This is actually strong clinical evidence that support the intervention of NIDCAP and as a result I cannot support their reasoning for excluding such strong supporting evidence.
It is extremely disappointing that the authors spend so much energy to discredit a well-researched, humane and respectful care model, rather than designing good research studies to generate solid evidence for alternative care to improve newborn development and outcomes.
Conflict of Interest:
None declared
Response to Ohlsson and Jacobs Article
March 4, 2013
Dear Editor,
This letter is written in response to the Ohlsson and Jacobs article, entitled "NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials." This is the fourth critical review and meta-analysis of NIDCAP that these authors have undertaken (1993, 2002, 2007, and now 2013). It appears that they have not grasped the difference between a NIDCAP? bedside observation and the administration of the Assessment of Preterm Infants' Behavior (APIB); nor, as in prior papers, is their abstract and conclusion (i.e., NIDCAP does not work) supported by their own findings.
Reading beyond Ohlsson and Jacobs abstract and conclusions one finds that NIDCAP has numerous statistically significant benefits, including: 1) reduced length of hospitalization; 2) younger (post-menstrual age) at discharge which presumably leads earlier to normalization of the infant's environment and care at home; 3) improved daily weight gain 4) improved Bayley MDI scores at 9 months CA; 5) improved Bayley PDI scores at 9 months; and 6) improved scores at 2 weeks CA on the APIB and Prechtl's Neurological Examination of the Fullterm Newborn. These results above, are reported by Ohlsson and Jacobs (2013) themselves.
There are not many, if any, medical interventions utilized in the NICU that have as many benefits as the NIDCAP approach to care does. NIDCAP requires no machines and no medications. It does require, however, that one is emotionally attuned to accept and embrace that an infant, no matter how small and fragile, is a person. A person who communicates to those around him what stresses him and what makes him comfortable. A person who can depend upon the loving nurturance of his mother and father. Parents are the key advocates for their infant and therefore must be included in the NICU and in all care giving offered to their infant.
Implementing NIDCAP is hard work for all those traditionally trained to be task- and procedure-oriented in the provision of care. Task skills are critically important, yet the task and procedures must be adapted and tailored to and implemented in collaboration with each infant and each family.
NIDCAP is clinically and intuitively appealing; humane and respectful of all infants and their families; has consistently good results;1-7 and has led to major changes in how NICUs are built, how intensive care is delivered, and how staff are educated and nurtured. NIDCAP is the most humane and comprehensive model of care that is available, and it has sufficient evidence-based research to back it up.
Sincerely,
Rodd E Hedlund, MEd Director, NIDCAP Nursery Certification Program (NNCP) NIDCAP Trainer Mid-Atlantic NIDCAP Center Children's Regional Hospital, Cooper University Hospital Camden, NJ 08103
James M. Helm. PhD Director, Carolina NIDCAP Training Center Infant Family Specialist WakeMed - Raleigh, Neonatology Raleigh, NC 27610
Bette Liberman Flushman, MA Infant Development Specialist Newborn Intensive Care Unit Children's Hospital & Research Center Oakland, California
Jean Gardner Cole, M.S. Director of NIDCAP Training at Boston Medical Center, Retired Adjunct Instructor in Pediatrics Boston University School of Medicine, Retired Master Trainer in NBAS, Child Development Unit, Children's Hospital, Boston. Mass. Emeritus
Terri H. Daniels, MEd NICU Developmental Specialist University of Southern Mississippi & Forrest General Hospital Hattiesburg, MS
Susann Hill-Mangan, MA,LPC,NBCC NIDCAP Trainer Emeritus Yuma, Arizona
Lindsay Lightbody, MA NIDCAP Trainer-in-Training
References:
1. Stevens B, Petryshen P, Hawkins J, Smith B, Taylor P. Developmental versus Conventional care: A comparison of clinical outcomes for very low birth weight infants. Can J Nurs Res. 1996; 28:97-113.
2. Westrup B, Kleberg A, Wallin L, Lagercrantz H, Wikblad K, Stjernqvist K. Evaluation of the newborn individualized developmental care and assesment program(NIDCAP?) in a Swedish setting. Prenatal and Neonatal Medicine. 1997; 2: 366-375.
3. Kleberg A, Westrup B, and Stjernqvist K. Developmental outcome, child behavior and mother-child interaction at 3 years of age following Newborn Individualized Developmental Care and Intervention Program (NIDCAP) intervention. Early Hum Dev. 2000; 60; 123-135.
4. Buehler, DM, Als H, Duffy FH, McAnulty GB and Liederman J. Effectiveness of individualized developmental care for low-risk preterm infants: Behavioral and electrophysiological evidence. Pediatrics, 1995; 96: 923-932.
5. Westrup B, Kleberg A, von Eichwald K, Stjernqvist K, and Lagercrantz H. A randomized controlled trial to evaluate the effects of the Newborn Individualized Developmental Care and Assessment Program in a Swedish setting. Pediatrics. 2000; 105(1): 66- 72.
6. Als H, Gilkerson L, Duffy FH, McAnulty GB, Buehler DM, VandenBerg K, Sweet N, Sell E, Parad RB, Ringer SA, Butler SC, Blickman JG, Jones KJ. A three-center randomized controlled trial of individualized developmental care for very low-birth-weight preterm infants: Medical, neurodevelopmental, parent and care giving effects. J Dev Behav Pediatr. 2003; 24:399-408.
7. Als, H., Duffy, F. H., McAnulty, G. B., Rivkin, M. J., Vajapeyam, S., Mulkern, R. V., Warfield, S., H?ppi, P. S., Butler, S., Conneman, N., Fischer, C., & Eichenwald, E. (2004). Early experience alters brain function and structure. Pedia, 113(4), 846-857.
Conflict of Interest:
Director, NIDCAP Nursery Certification Program (NNCP) NIDCAP Trainer Mid-Atlantic NIDCAP Center Children's Regional Hospital, Cooper University Hospital Camden, NJ 08103
Response to NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials
Dear Editor,
After reading and re-reading NIDCAP: A Systematic Review and Meta- analyses of Randomized Controlled Trials, by Arne Ohlsson and Susan E. Jacobs, it appears not to be a true representation or evaluation of the NIDCAP research and work. Dr. Als and the NIDCAP organization have never proposed that death, survival free of any disability, cerebral palsy, visual impairment, or sensori-neural hearing loss be measured NIDCAP outcomes. Indeed medical treatment to ameliorate those outcomes would be outstanding, however living in the NICU environment during a time of critical brain development when the early born baby is not prepared to manage him/herself can have a most dramatic impact.
Outcomes that have been measured by NIDCAP with statistically significant outcomes include: shorter hospital length of stay, earlier PMA discharge, improved daily weight gain, improved Bayley MDI and PDI scores at 9 months, significantly improved APIB scores and significantly improved EEG and MRI findings.
As the authors stated in the article, "modification of the extrauterine NICU environment and caregiving according to each infant's current physiologic and neurobehavioral functioning is a rational and intuitive approach to caring for infants and their families and to supporting infant development". This, along with decades of research, are at the core of NIDCAP.
The Sooner NIDCAP Training Center in Oklahoma has been functioning since 1985. Overall NIDCAP care is acknowledged by nursing and medical staff as well as other hospital disciplines (occupational therapy, physical therapy, speech therapy, respiratory therapy, child life, volunteers) as the way to support infants to participate in their care and get the most from the necessary components of treatment. Nursing and medical staff support, teach and encourage families to participate and provide the level of care that promotes infant-parent attachment from the first day.
I hope you will review the article again for inaccuracies and biases. NIDCAP should not have to suffer from an unfair and biased analysis. Thank you, Eleanor Hutson, RN Co-director Sooner NIDCAP Training Center Oklahoma Infant Transition Program OU Health Sciences Center Oklahoma City, Oklahoma
Conflict of Interest:
None declared
From the Japan Assoiation of Research on Developmental Care
The review article titled NIDCAP: A Systematic Review and Meta- analyses of Randomized Controlled Trials by Arne Ohlsson and Susan E. Jacobs (PEDIATRICS Volume 131, Number 3, March 2013, e881- e893) gave us encouragement to pursue our activity to introduce NIDCAP to Japan in spite of their misleading conclusion, because their data shows better outcomes of infants cared by NIDCAP in several aspects without any ill effects or hazard by NIDCAP. Currently Japanese statistics on survival rates and long term outcome of premature infants, especially extremely low birth weight infants, are better than those of North America and of European countries. But we are concerned about relatively high incidence of ADHA/Autistic disorder/learning disorder among those who escape from major neurological handicaps such. These disorders are known to be related with high degree brain functions impairment and are speculated to occur by continuous excessive stress to these preemies during their stay in the NICU. Therefore we are now switching our mind of caring for these high-risk infants from aggressive medical treatments to save life and to lower major neurological sequelae, to gentle care of nurturing warm heartedness. There are also substantial basic research studies to support this approach, such as increment of apoptosis of neurons at frontal lobe and so on. We know statistics often smokes the clinical data from the reality, especially those of multifactorial clinical outcome. As far as their article shows that NIDCAP does not hamper the outcome of premature infants, we continue to provide gentleness to our most vulnerable preemies while improving our modalities and skills for their better outcome.
Hiroshi Nishida MD, PhD, FAAP Honorary Professor, Tokyo Women's Medical University Japan Association of Research on Developmental Care
Conflict of Interest:
None declared
Concerning NIDCAP: A systematic review
I would like to comment on Ohlsson and Jacobs' article NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials. Other professionals will detail the flaws in their meta-analysis, including their choice of outcome measures and lack of basic knowledge of what NIDCAP is and requires as is clearly seen in their last two paragraphs where they confuse NIDCAP as needing APIB assessment, clustered care and incubator covers. One would hope that researchers doing a meta-analysis would have a greater knowledge of the subject they are researching, which begs to question how they actually reviewed and analyzed the information, seeing as much of the evidence they provided supported NIDCAP's effectiveness. However, I want to focus on the concept of risk and its importance in evidence based health care practice. The greater the risk to the patient of any intervention, the more robust the evidence required before change is made. With interventions that pose low or no risk to the health of the patient, the professional or institution may consider other reasons to justify implementing the practice change.
NIDCAP has no side effects; it provides no risk to the infant. It has benefits to the family, in that parents have an enhanced view of their infant1, feel closer to their infant 2, and feel more satisfied with the nursing care3,4. In an age where patient satisfaction will be an increasingly important factor in hospital reimbursement, this is no trivial thing. Joint Commission advocates for adopting patient and family- centered care and NIDCAP implementation does that for the neonatal population. It is a humane way of looking at infants and planning care to reduce stress and promote regulated functioning. The fact that Ohlsson and Jacobs looked at whether NIDCAP reduces mortality (which was never the goal in any of the studies they reviewed) and did not highlight the behavioral outcomes, did not include the MRI and EEG evidence nor the potential benefits to the families or the hospitals reveals a short sighted view.
I believe there is good evidence to support NIDCAP, but even if there was not, NIDCAP is an important strategy for hospitals to meet the growing expectations of families who wish to be intimately involved in the care of their child and to understand what their child is communicating non- verbally. We all know the importance of a quality relationship between infant and parents in driving overall development; NIDCAP is an important tool for supporting that.
1. Als H, Gilkerson L, Duffy FH, McAnulty GB, Buehler, DM, VandenBerg KA, Sweet N, Sell E, Parad RB, Ringer S A, Butler S, Blickman JG & Jones KJ (2003). A three-center randomized controlled trial of individualized developmental care for very low birth weight preterm infants: Medical, neurodevelopmental, parenting and caregiving effects. Journal of Developmental Behavioral Pediatrics.24(6), 399-408.
2. Kleberg A, Hellstr?m-Westas L & Widstr?m A-M (2007). Mothers' perception of newborn individualized developmental care and assessment program (nidcap) as compared to conventional care. Early Human Development. 83(6), 403-411.
3. van der Pal SM, Maguire CM, Le Cessie S, Veen S, Wit JM, Walther FJ, Veen S (2008). Parental stress and child behavior and temperament in the first year after the newborn individualized developmental care and assessment program. Journal of Early Intervention. 30(2), 102-115.
4. Wielenga, JM, Smit, BJ & Unk, LK (2006). How satisfied are parents supported by nurses with the NIDCAP model of care for their preterm infant? Newborn individualized developmental care and assessment program. Journal of Nursing Care Quality. 21(1), 41-48.
Conflict of Interest:
None declared
Is this NIDCAP effects metanalysis valid?
Sari Goldstein Ferber, PhD Ministry of Health, Israel Department of State Alumni USA ( Fulbright New Century Scholar) ferbers@post.tau.ac.il
In the paper by Arne Ohlsson & Susan E. Jacobs published recently in Pediatrics the conclusions suggest that the NIDCAP method is unworthy i.e. does not show to improve the medical status of preterm infants. There are several faults is reaching this conclusion. The NIDCAP method is designed to improve brain development, mental development, adaptation to the out uterine environment and decrease in developmental delays. The NIDCAP method has been designed to work on the results of increased survival rates due to better technology used by the neonatologists which in turn results in survival of early gestational age infants and increased mental, motor, cognitive, and psychological and adaptation delays of those infants. NIDCAP method was not designed to increase survival rates and therefore some of the outcome measures in this metanalysis are not relevant. The method section is not detailed enough so no replication of this metanalysis by other groups is possible. In the results section figures 3 and 4 show significant effects for mental developmental supported by NIDCAP. However, the authors contradict themselves in the discussion section by not discussing the significant effects in figures they show. The results section in a true metanalysis should mention at least one of the following: D, square eta, square R or beta. None of these appear in this results section. In addition, there is no risk discussion regarding the results of this particular metanalysis concerning the challenge of any metanalysis which needs to accomplish the gathering different populations, subjects, group sizes, outcome measures and seasonal differences. At least for the lighting parameter in the NIDCAP method seasonal effects are relevant (Ferber et al. 2011). NIDCAP method combines many parameters that were reported in the literature as supportive for the preterm infant such as decreasing of light and noise as well as implementation of Kangaroo Care and supporting coregulation of neurobehavioral subsystems ( Ferber & Makhoul 2004 (cited by 168 papers to date) Ferber & Makhoul 2008, Ferber 2008 (impact factor 12.181), Ferber et al 2011). There are many supportive results on these parameters from other groups around the globe published in distinguished journals including Pediatrics. No conclusion can be made on NIDCAP improving effects without inclusion of this systematic portion of controlled trials which were not included in this metanalysis. Therefore, the careful reader will judge this metanalysis by Arne Ohlsson & Susan E. Jacobs as a story without statistical and internal validity.
References: Ferber, S.G., & Makhoul R.I. (2004). The effect of Skin-to Skin Contact (Kangaroo Care) shortly after birth on the neurobehavioral responses of the full-term newborn: A randomized controlled trial. Pediatrics, 113, 858-865
Ferber, S.G., & Makhoul I.R. (2004). The effect of Kangaroo Care immediately after birth on neurobehavioral responses of the full-term neonate. (special volume: Current Best Evidence). Journal of Pediatrics. 145, 683-684, Awarded as the Best Evidence by The Journal of Pediatrics Ferber S.G., & Makhoul, IR.(2008) .Neurobehavioral assessment of Kangaroo Care (Skin-to -Skin) effects on immediate and sustained reaction to pain in preterm infants: A randomized controlled within-subject trial, Acta Pediatrica, 97(2):171-6 Ferber, S.G. (2008). The Concept of Co-Regulation between Neurobehavioral Sub-Systems: the Logic Interplay between Excitatory and Inhibitory Ends. Behavioral and Brain Sciences. 31, 337-338 Ferber, S.G., Als, H., McAnulty, G., Peretz, H., Zisapel, N. Melatonin and mental capacities newborn infants .The Journal of Pediatrics. 159 ( 1) , 99-103
Conflict of Interest:
None declared