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NCT Number: NCT05675397

Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants

This prospective randomized controlled trial aims to investigate whether feeding very low birth weight (VLBW) infants with Mother's own milk (MOM) supplemented with either preterm (PDM) or term donor milk (TDM), when MOM is insufficient, has a positive impact on infants' protein intake, growth and morbidity.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Department of Pediatrics, National and Kapodistrian University of Athens, Athens, Greece

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About this study

Mother's own milk (MOM) is the optimal nutrition for preterm infants. When MOM is not sufficient, pasteurized donor milk (DM) is the best alternative according to current recommendations. Donor milk is primarily derived from mothers of term-born infants for the first six months of lactation. However, this term milk presents significant differences compared to preterm human milk which has higher protein concentration and more caloric energy.

The investigators hypothesized that feeding VLBW infants with preterm donor milk (PDM) in combination with MOM may positively influence the protein intake and, consequently, the infants' growth. The aim of the current study is to assess whether MOM supplementation with PDM has any beneficial effects on the nutrition, growth and morbidity in VLBW infants.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Donor Human Milk

Dietary Supplement

Pasteurized preterm donor milk (PDM) versus term donor milk (TDM) will be provided to the study population following randomization, as supplementary to mother's own milk (MOM) or as alternative feeding

Primary outcomes

  1. Assessment of infants' growth

    Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)

    Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B.

  2. Assessment of protein intake

    Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)

    Protein intake by the study participants during hospitalization (grams per Kg of body weight per day) will be assessed and compared between group A and group B.

  3. Assessment of morbidity

    Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)

    Culture positive sepsis in study participants during hospitalization will be assessed and compared between group A and group B.

Study contacts

Contact information is provided by the study sponsor or research team.

Giannoula Gialeli, MD

CONTACT

[email protected]

+30 2109758491

Tania Siahanidou, MD, PhD

CONTACT

[email protected]

+30 2132013517

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 9, 2023
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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