Immediate Skin-to-Skin Contact in Very Preterm Neonates and Early Childhood Neurodevelopment: A Randomized Clinical Trial.

Abstract

Preterm neonates are at risk for neurodevelopmental impairments, and there is a need to identify protective factors that can modify the harmful effects of preterm birth on the immature brain. To evaluate whether immediate skin-to-skin contact (SSC) for preterm neonates improves early childhood neurodevelopmental outcomes. This open-label randomized clinical trial was conducted in 3 Norwegian neonatal units between February 2014 and October 2020. Participants were preterm neonates born at 28 weeks 0 days' to 31 weeks 6 days' gestation with birth weight greater than 1000 g and no major congenital malformations or need for intubation or oxygen supplementation of more than 40%. Intention-to-treat analysis was conducted from July 2023 to July 2024. Neonates were randomized 1:1 to immediate SSC between mother and neonate in the delivery room for 2 hours or to standard care with direct transport to the neonatal unit in an incubator. The primary outcome was cognitive development at 2 to 3 years of age, measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III). Secondary outcomes were language and motor neurodevelopment measured by the BSID-III, parental questionnaires at 3 and 12 months and 2 to 3 years, and breastfeeding practices up to 12 months. Of 108 included neonates (68 [63%] male; mean [SD] gestational age, 30 weeks 3 days [1 week 1 day]), 51 received SSC and 57 received standard care. Eighty-six (80%) had follow-up at 2 to 3 years, and 81 (75%) completed the BSID-III and were analyzed for the primary outcome. The mean difference in BSID-III cognitive composite scores was 0.21 (95% CI, -5.26 to 5.68; P = .94). There was no difference between the groups in the proportion at risk of developmental delay at 2 to 3 years: 21 of 41 (51%) and 22 of 45 (49%) in the SSC and standard care groups, respectively (odds ratio, 1.10 [95% CI, 0.47-2.56]; P = .83). More neonates in the SSC group were breastfed at hospital discharge (42 of 50 [84%] vs 36 of 54 [67%]; P = .04). In this randomized clinical trial, 2 hours of mother-neonate SSC in the delivery room did not enhance neurodevelopmental outcomes at 2 to 3 years of age. However, the SSC group demonstrated improved breastfeeding practices up to 12 months compared with standard care, suggesting that the feasible and low-cost SSC intervention should be encouraged in clinical practice. ClinicalTrials.gov Identifier: NCT02024854.