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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675397
• Other study ID #: 6116
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2027

Study information

• Verified date: December 2022
• Source: National and Kapodistrian University of Athens
• Contact: Tania Siahanidou, MD, PhD
• Phone: +30 2132013517
• Email: siahan[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

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

Locations

Country	Name	City	State
Greece	First Department of Pediatrics, National and Kapodistrian University of Athens	Athens
Greece	Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)