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

RecruitingNAAges 1 Day - 90 DaysAllThe Children's Hospital of Zhejiang University Sc…
NCT07045844 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are: Does supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering? Researchers will compare: pHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment. Participants will: Be randomized

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📋 Eligibility rules (as published)
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;
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What it tests

  • Pasteurized Donor Milk for Insufficient Breastfeeding
  • Preterm Formula for Insufficient Breastfeeding
  • Routine fortification
  • Rescue fortification
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Where

24 sites
The First Affiliated Hospital of Guilin Medical University
Guilin, China
Yulin Maternity and Child Health Care Hospital, Guangxi
Yulin, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Hubei Maternity and Child Health Care Hospital
Wuhan, China
Yiyang Central Hospital
Yiyang, China
Inner Mongolia Autonomous Region Maternity and Child Health Care Hospital
Hohhot, China
Ganzhou Maternal and Child Health Hospital
Ganzhou, China
Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital)
Yinchuan, China

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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