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

Primary Purpose

Prematurity

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

donor human milk

About this trial

This is an interventional prevention trial for Prematurity focused on measuring preterm infants, nutrition, donor milk, breast milk

Eligibility Criteria

1 Day - 3 Weeks (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal HospitalRecruiting
First Department of Pediatrics, National and Kapodistrian University of Athens

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MOM supplemented with PDM (group A)

MOM supplemented with TDM (group B)

Arm Description

VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)

VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)

Outcomes

Primary Outcome Measures

Assessment of infants' growth

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

Assessment of protein intake

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.

Assessment of morbidity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05675397

First Posted

December 14, 2022

Last Updated

December 21, 2022

Sponsor

National and Kapodistrian University of Athens

1. Study Identification

Unique Protocol Identification Number

NCT05675397

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2022 (Actual)

Primary Completion Date

December 2026 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prematurity

Keywords

preterm infants, nutrition, donor milk, breast milk

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MOM supplemented with PDM (group A)

Arm Type

Experimental

Arm Description

VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)

Arm Title

MOM supplemented with TDM (group B)

Arm Type

Active Comparator

Arm Description

VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)

Intervention Type

Dietary Supplement

Intervention Name(s)

donor human milk

Intervention Description

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 Outcome Measure Information:

Title

Assessment of infants' growth

Description

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

Time Frame

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

Title

Assessment of protein intake

Description

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.

Time Frame

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

Title

Assessment of morbidity

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

3 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tania Siahanidou, MD, PhD

Phone

+30 2132013517

siahan@med.uoa.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Giannoula Gialeli, MD

Phone

+30 2109758491

giannoula.g@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Liosis, MD, PhD

Organizational Affiliation

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Giannoula Gialeli

Organizational Affiliation

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tania Siahanidou

Organizational Affiliation

First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens

Official's Role

Study Director

Facility Information:

Facility Name

Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital

City

Athens

ZIP/Postal Code

11521

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Giannoula Gialeli, MD

Phone

+30 2109758491

giannoula.g@gmail.com

First Name & Middle Initial & Last Name & Degree

Anastasia Kapetanaki, MD

Phone

+302132051000

nancykap@icloud.com

First Name & Middle Initial & Last Name & Degree

Giannoula Gialeli, MD

First Name & Middle Initial & Last Name & Degree

Anastasia Kapetanaki, MD

Facility Name

First Department of Pediatrics, National and Kapodistrian University of Athens

City

Athens

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tania Siahanidou, MD, PhD

Phone

+30 2132013517

siahan@med.uoa.gr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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