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

Starting soon · Not applicable

Conditions studied: Very Preterm Infant, Necrotizing Enterocolitis (NEC)

In brief

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 twice: * First, within the first week of life to receive either pHDM or PTF when OMM is insufficient * Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the PARCA-R tool (no additional study visits required) This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes. COLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.

Key facts

Study ID

NCT07045844

Run by

The Children's Hospital of Zhejiang University School of Medicine

People needed

2324

Starts

2026-03-02

Expected to finish

2030-07-31

Last updated by the study team

2026-02-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age at birth less than 29 weeks;
• No contraindications to enteral feeding;
• Mother is willing to breastfeed.

You may not qualify if…

• 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;

Where it is running

• The First Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China
• The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
• Yulin Maternity and Child Health Care Hospital, Guangxi — Yulin, Guangxi, China
• The Affiliated Hospital of Guizhou Medical University — Guizhou, Guiyang, China
• Nanyang Central Hospital — Nanyang, Henan, China
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Yiyang Central Hospital — Yiyang, Hunan, China
• Ganzhou Maternal and Child Health Hospital — Ganzhou, Jiangxi, China
• Peking University First Hospital Ningxia Women and Children's Hospital (Ningxia Hui Autonomous Region Maternal and Child Health Hospital) — Yinchuan, Ningxia, China
• Shandong Provincial Maternal and Child Health Care Hospital — Jinan, Shandong, China
• Sichuan Provincial Maternal and Child Health Hospital — Chengdu, Sichuan, China
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang Uygur Autonomous Region, China
• Yongkang Maternity and Child Health Care Hospital — Guli, Zhejiang, China
• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Women's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Hangzhou Women's Hospital — Hangzhou, Zhejiang, China
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Jiaxing Maternity and Child Health Care Hospital — Jiaxing, Zhejiang, China
• Ningbo Women and Children's Hospital (The Affiliated Women and Children's Hospital of Ningbo University) — Ningbo, Zhejiang, China
• Yiwu Maternity and Child Health Care Hospital (Yiwu Branch of The Children's Hospital, Zhejiang University School of Medicine) — Yiwu, Zhejiang, China

Full record on ClinicalTrials.gov

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