Effect of donor milk or formula and fortification strategies on outcomes in very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study randomizes infants born before 29 weeks gestation to receive either pasteurized donor human milk or preterm formula when maternal milk is insufficient. It also compares routine fortified human milk to selective fortification based on growth needs. The primary goal is to see if these feeding strategies improve survival without surgery-requiring NEC by 34 weeks gestational age, and to determine which fortification approach best supports growth and neurodevelopment. Participants are assigned in two randomization steps within the first week of life. The trial is conducted across multiple Chinese and UK sites with international collaboration.

Why it matters

Who can join: the full rules

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;

Where it's running

• The First Affiliated Hospital of Guilin Medical University
  Guilin, Guangxi, China Recruiting
• Yulin Maternity and Child Health Care Hospital, Guangxi
  Yulin, Guangxi, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Hubei Maternity and Child Health Care Hospital
  Wuhan, Hubei, China Recruiting
• Yiyang Central Hospital
  Yiyang, Hunan, China Recruiting
• Ganzhou Maternal and Child Health Hospital
  Ganzhou, Jiangxi, China Recruiting

Study contacts

• Study coordinator: Yanping Xu
• Email: xuyanping726@zju.edu.cn
• Phone: 8613685757726

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fortifying human milk for very preterm and low birthweight infants

  This study is testing if feeding very preterm and low birthweight babies fortified human milk in NICUs can help them grow better, get less sick, and live longer compared to regular feeding methods.

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• Using AI to predict necrotizing enterocolitis in premature babies through stool analysis

  This study is trying to see if using AI to analyze stool samples from premature babies can help predict who is at risk for necrotizing enterocolitis, so doctors can take steps to prevent it.

  Recruiting at 2 sites University Hospital, Clermont-Ferrand · Clermont-Ferrand and 4 other locations · NCT06727877

• FMT as a preventive measure for NEC in premature infants

  This study tests whether giving fecal microbiota transplantation to preterm babies can safely prevent necrotizing enterocolitis.

  Recruiting Medical University of Warsaw · Warsaw, Mazovian Voivodeship · NCT06333405

• NETs — protective or harmful in newborn inflammation and infection?

  We will test how immune cells from very premature babies at risk for NEC make proteins when exposed to a substance called PAF, comparing them with cells from healthy term infants and adults.

  Recruiting University of Utah · Salt Lake City, Utah · NCT00747851

• Delayed vs Immediate Umbilical Cord Clamping in Preterm Birth

  This trial tests whether delaying the clamping of the umbilical cord after birth helps preterm babies more than clamping right away.

  Recruiting Faculty of Medicine of Tunis · Tunis, Tunis Governorate · NCT07699666

• Early warning system for neonatal NEC to help predict risk in very preterm babies

  A multicenter observational study in preterm newborns to see if combining genetic data and immune markers with clinical info can better predict necrotizing enterocolitis than clinical data alone.

  Recruiting at 2 sites Guangzhou Women and Children's Medical Center · Guangxi, Guangxi and 1 other locations · NCT07545993

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.