Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how different feeding methods affect very premature babies born before 29 weeks of pregnancy. Specifically, it looks at whether giving these babies pasteurized donor breast milk (milk from another mother) or special preterm formula, when their own mother’s milk isn’t enough, helps them survive without developing a serious gut problem called necrotizing enterocolitis (NEC). The study also wants to find out if adding extra nutrients to human milk all the time (routine fortification) is better than adding them only if the baby isn’t growing well (selective fortification).

Babies who join the study will be randomly assigned to receive either donor milk or preterm formula if their mother’s milk is insufficient, and then later, they will be randomly assigned to receive either routine or selective fortification of their milk. The feeding and care will follow usual hospital practices, and the babies’ development will be checked at 2 years of age with a simple assessment. To be eligible, babies must be born very early (before 29 weeks), able to be fed by mouth or tube, and have a mother willing to breastfeed. This study is designed to fit into normal hospital care and hopes to provide important information to improve feeding and health outcomes for very preterm infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Gestational age at birth less than 29 weeks;
• • No contraindications to enteral feeding;
• • Mother is willing to breastfeed.
• Exclusion Criteria:
• • For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;
• • For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;