NCT05675397

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 1, 2022

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 9, 2023

Status Verified

December 1, 2022

Enrollment Period

4 years

First QC Date

December 14, 2022

Last Update Submit

December 21, 2022

Conditions

Prematurity

Keywords

preterm infantsnutritiondonor milkbreast milk

Outcome Measures

Primary Outcomes (3)

  • Assessment of infants' growth

    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

    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

    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)

Study Arms (2)

MOM supplemented with PDM (group A)

EXPERIMENTAL

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

Dietary Supplement: donor human milk

MOM supplemented with TDM (group B)

ACTIVE COMPARATOR

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

Dietary Supplement: donor human milk

Interventions

donor human milkDIETARY_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

MOM supplemented with PDM (group A)MOM supplemented with TDM (group B)

Eligibility Criteria

Age1 Day - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Athens, 11521, Greece

RECRUITING

First Department of Pediatrics, National and Kapodistrian University of Athens

Athens, 11527, Greece

NOT YET RECRUITING

Related Publications (1)

  • Gialeli G, Kapetanaki A, Panagopoulou O, Vourna P, Michos A, Kanaka-Gantenbein C, Liosis G, Siahanidou T. Supplementation of Mother's Own Milk with Preterm Donor Human Milk: Impact on Protein Intake and Growth in Very Low Birth Weight Infants-A Randomized Controlled Study. Nutrients. 2023 Jan 21;15(3):566. doi: 10.3390/nu15030566.

    PMID: 36771273DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • George Liosis, MD, PhD

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

    STUDY CHAIR

  • Giannoula Gialeli

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

    PRINCIPAL INVESTIGATOR

  • Tania Siahanidou

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

    STUDY DIRECTOR

Central Study Contacts

Tania Siahanidou, MD, PhD

CONTACT

+30 2132013517siahan@med.uoa.gr

Giannoula Gialeli, MD

CONTACT

+30 2109758491giannoula.g@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Pediatrics-Neonatology

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 9, 2023

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 9, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)