Supplementing mother's milk with donor milk for preterm infants
Official title: Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
Run by National and Kapodistrian University of Athens · NCT05675397 · Data updated 2026-11-12
This study is testing if adding donor milk to the mother's milk helps very low birth weight babies grow better and stay healthier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 3 Weeks |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 2 sites (Athens and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2027 |
| Registry record updated | January 9, 2023 |
| Trial ID | NCT05675397 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are VLBW infants with a birth weight of less than 1500g whose mothers can provide donor milk.
✕Probably not a fit
Patients with congenital anomalies, chromosomal disorders, metabolic diseases, or those fed formula during the first three weeks will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized controlled trial investigates the effects of supplementing very low birth weight (VLBW) infants' mother's own milk (MOM) with either preterm donor milk (PDM) or term donor milk (TDM) when MOM is insufficient. The study aims to determine if this supplementation positively impacts protein intake, growth, and morbidity in these infants. The hypothesis is that PDM, which has a higher protein concentration than TDM, will provide better nutritional support for VLBW infants. The trial will assess the outcomes over the first three weeks of life.
Why it matters
Potential benefit: If successful, this approach could enhance the nutritional intake and overall health outcomes of VLBW infants.
How similar studies have gone: Previous studies have shown positive outcomes with donor milk supplementation in preterm infants, suggesting this approach is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • VLBW infants with birth weight \<1500g born to mothers who agree to provide donor milk for the first three weeks of life (donor milk period) if their own milk quantity is insufficient Exclusion Criteria: * Congenital anomalies * Chromosomal disorders * Metabolic diseases * Feeding with formula at any point during the first 3 weeks of life (donor milk period)
Where it's running
-
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
Athens, Greece Recruiting -
First Department of Pediatrics, National and Kapodistrian University of Athens
Athens, Greece Not yet recruiting
Study contacts
- Principal investigator: Giannoula Gialeli — Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
- Study coordinator: Tania Siahanidou, MD, PhD
- Email: siahan@med.uoa.gr
- Phone: +30 2132013517
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.