Supplementing mother's milk with donor milk for preterm infants
Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 1 Day to 3 Weeks |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 2 sites (Athens and 1 other locations) |
| Trial ID | NCT05675397 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are VLBW infants with a birth weight of less than 1500g whose mothers can provide donor milk.
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.
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 performed: Previous studies have shown positive outcomes with donor milk supplementation in preterm infants, suggesting this approach is promising.
Eligibility criteria
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 this trial is running
Athens and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.