Clinical trial Recruiting at 1 site Interventional Ages 1 Day to 3 Weeks

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.

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Quick facts

Study typeInterventional
Ages1 Day to 3 Weeks
SexAll
Enrollment200 (estimated)
SponsorNational and Kapodistrian University of Athens
Academic / other
Locations2 sites (Athens and 1 other locations)
StatusRecruiting
StartedDecember 1, 2022
Main results expectedDecember 2026
Study endsDecember 2027
Registry record updatedJanuary 9, 2023
Trial IDNCT05675397 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

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.