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

December 21, 2022 updated by: Soultana (Tania) Siahanidou, National and Kapodistrian University of Athens

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tania Siahanidou, MD, PhD
  • Phone Number: +30 2132013517
  • Email: siahan@med.uoa.gr

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 11521
        • Recruiting
        • Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giannoula Gialeli, MD
        • Sub-Investigator:
          • Anastasia Kapetanaki, MD
      • Athens, Greece, 11527
        • Not yet recruiting
        • First Department of Pediatrics, National and Kapodistrian University of Athens
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MOM supplemented with PDM (group A)
VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)
Dietary supplement: donor human milk
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
Active Comparator: MOM supplemented with TDM (group B)
VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)
Dietary supplement: donor human milk
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
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.
From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
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.
From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Study Chair: George Liosis, MD, PhD, Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
  • Principal Investigator: Giannoula Gialeli, Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
  • Study Director: Tania Siahanidou, First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

December 1, 2026

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

January 9, 2023

Study Record Updates

Last Update Posted (Estimate)

January 9, 2023

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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