NIDCAP: A Systematic Review and Meta-analyses of Randomized Controlled Trials

BACKGROUND AND OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: This systematic review including 627 preterm infants did not find any evidence that NIDCAP improves long-term neurodevelopmental or short-term medical outcomes. Pediatrics 2013;131:e881–e893 AUTHORS: Arne Ohlsson, MD, MSc, FRCPCab and Susan E. Jacobs, MBBS, MD, FRACPcde aProfessor Emeritus Departments of Paediatrics, Obstetrics and Gynaecology, Health Policy, Management and Evaluation, University of Toronto, Ontario Canada; bHonorary Consultant Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada; cNeonatal Services, Royal Women’s Hospital, Melbourne, Victoria, Australia; dCritical Care and Neurosciences, Murdoch Childrens Research Institute, Melbourne, Victoria, Australia; and eDepartment of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia KEY WORD Newborn Individualized Developmental Care and Assessment Program (NIDCAP) ABBREVIATIONS APIB—Assessment of Premature Infant Behavior BSID—Bayley Scales of Infant Development BWH—Brigham Women’s Hospital CA—corrected age CHB—Children’s Hospital Boston CHO—Children’s Hospital Oakland CI—confidence interval CLD—chronic lung disease MD—mean difference MDI—Mental Development Index NIDCAP—Newborn Individualized Developmental Care and Assessment Program PDI—Psychomotor Development Index PMA—postmenstrual age PRISMA—preferred reporting items for systematic reviews and meta-analyses RCT—randomized controlled trial RR—relative risk WISC-R—Wechsler Intelligence Scale for Children – Revised WPPSI-R—Wechsler Preschool and Primary Scale For Children – Revised Drs Ohlsson and Jacobs made equal contributions to the conception, the design, the acquisition of data, the analysis and the interpretation of the data. Both authors participated in the drafting of the article and revised it critically for important intellectual content; and made the final approval of the version to be published. Both authors take public responsibility for the content of the article. www.pediatrics.org/cgi/doi/10.1542/peds.2012-2121 doi:10.1542/peds.2012-2121 Accepted for publication Oct 25, 2012 Address correspondence to Arne Ohlsson, MD, MSc, FRCPC, 105 Pinnacle St North, Brighton, Ontario, K0K 1H0, Canada. E-mail: [email protected] (Continued on last page) PEDIATRICS Volume 131, Number 3, March 2013 e881 REVIEW ARTICLE by guest on April 18, 2017 Downloaded from The “synactive” theory of neurobehavioral development, introduced by Als in the late 1970s, forms the basis of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP).1,2 It 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 caregiving intervention. After the assessment, recommendations for caregiving are provided to the bedside nurses and the infant’s family. Although individualized, the caregiving principles to reduce stress and promote physiologic stability are often generalized to include alteration of the environment (lower ambient light and sound), aids to promote flexion and self-regulation, clustering of care, and parental involvement in the care of their infant. The first published NIDCAP study hypothesized that the respiratory and functional states of the very low birth weight infants at risk for bronchopulmonary dysplasia would be improved by preventing inappropriate sensory input.3 This phase-lag study lacked power, enrolling only 16 infants over 2 years. Baseline characteristics favored the NIDCAP group, suggesting very selective enrollment. Some outcomes reported had occurred in the NIDCAP group before initiation of the study intervention.4 Since then, several small unmasked randomized controlled trials (RCTs) assessing the effectiveness of NIDCAP in improving either short-term medical and/or neurodevelopmental outcomes have been published. Since 1993, systematic reviews of NIDCAP have been conducted.4–11 Reviewers agree that, based on small sample sizes and poor study quality, there was insufficient high-quality evidence regarding the NIDCAP on which to base clinical practice and that further well-conducted RCTs were needed. Several larger trials were published from 2009 to 2012 justifying this update of our previous reviews.4,5,8