Preventive intervention program on the outcomes of very preterm infants and caregivers: A multicenter randomized controlled trial

Increased survival in the very preterm population results in a higher risk of developing neurodevelopmental and behavioral disabilities among survivors. We examined the outcomes of very preterm infants and parents after a preventive intervention program of four home visits by a specialized nurse, 5 days, 2 weeks, and 1 month after discharge, respectively, and at CA 2 months, followed by up to 12 times of group sessions between CA 3 and 6 months. Our multicenter randomized controlled trial assessed 138 preterm infants (gestational age ≤30 weeks or birth weight ≤1500 g) enrolled from the three participating hospitals. We randomly allocated the preterm babies to either the intervention or the control group. The primary outcome was the neurodevelopmental outcomes of Bayley-III scores at CA 10 and 24 months. At CA 10 months and 24 months, there were no significant differences between the intervention and control groups in the cognitive, motor, and language domains of Bayley-III scores. In addition, there were no significant differences in the mother’s depression scale, mother-child attachment, and the modified Infant and Toddler Social and Emotional Assessment.