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

Not Applicable

Recruiting

• Conditions: Prematurity
• Interventions: Dietary Supplement: donor human milk

• Registration Number: NCT05675397
• Lead Sponsor: National and Kapodistrian University of Athens

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-12
• Study Start: 2022-12-01
• Study First Submitted: 2022-12-14
• Study First Submitted QC: 2022-12-21
• Last Update Submitted: 2022-12-21
• Study First Posted: 2023-01-09
• Last Update Posted: 2023-01-09
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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Exclusion Criteria

• Congenital anomalies
• Chromosomal disorders
• Metabolic diseases
• Feeding with formula at any point during the first 3 weeks of life (donor milk period)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOM supplemented with PDM (group A)	donor human milk	VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)
MOM supplemented with TDM (group B)	donor human milk	VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)

Primary Outcome Measures

Name	Time	Method
Assessment of infants' growth	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.
Assessment of morbidity	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.
Assessment of protein intake	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.

Trial Locations

Locations (2)

First Department of Pediatrics, National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital; 🇬🇷 Athens, Greece