Background: In the context of a growing interest in developmental care (DC) this study explores the effect of the basic elements of DC and the additional effect of the individual approach of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) on the health-related quality of life (HRQoL) of very preterm infants at 1 year of age. The basic elements of DC in this study were defined as the use of standardized nests and incubator covers whose protective characteristics were hypothesized to have a positive effect on the infant's HRQoL. The individualized approach of the NIDCAP was thought to further increase HRQoL.
Methods: Very preterm (<or=32 weeks) born infants in a Dutch Neonatal Intensive Care Unit at two locations were included in two consecutive randomized controlled trials (RCT) comparing controls (standard care) with basic DC (standardized nests and covers) in the first RCT and basic DC with NIDCAP in the second RCT. Parents completed a questionnaire (RCT 1, n=136; RCT 2, n=128) regarding their infant's HRQoL (TNO-AZL Preschool Quality of Life Questionnaire) at 1 year of age, corrected for prematurity. Because of multiple testing a P-value of below 0.01 was chosen to indicate significance.
Results: HRQoL scores ranged from good to optimal for most infants. No significant differences were found between basic DC vs. controls and NIDCAP vs. basic DC on the child's HRQoL as reported by parents at 1 year of age.
Conclusions: These two RCT show that the basic elements of DC and the more individualized NIDCAP do not improve HRQoL of very preterm infants at 1 year of age.