Abstract

Research success means discovery of an orderly pattern that had not been recognized previously. The first Newborn Individualized Developmental Care and Assessment Program (NIDCAP) investigation in 1986, a small phase-lag trial, was dismissed because of design shortcomings.1 Nevertheless, it inspired some investigators. More rigorous trials soon followed and bore out the initial study's results.2–12 A recent randomized, controlled trial (RCT) with the largest sample to date (∼160 infants) from Leiden, Netherlands,13 did not show the benefits of this program as previously reported in multiple publications. What might account for this surprising failure to reject the null hypothesis? Several points are worthy of consideration: ∼15 infants total were newly enrolled every month in this study (ie, ∼2 new intervention group infants per week), which is an extraordinary number of infants in a small unit in which NIDCAP is not standard of care and represents a Herculean task. Weekly observations and report formulations constitute only a small part of NIDCAP. The relationship with each family and staff is the most important aspect of NIDCAP. … Address correspondence to Heidelise Als, PhD, Children's Hospital Boston, Neurobehavioral Infant and Child Studies, Enders Pediatric Research Building, En107, 320 Longwood Ave, Boston, MA 02115. E-mail: heidelise.als{at}childrens.harvard.edu or gloria.mcanulty{at}childrens.harvard.edu

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