Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Assessment of protein intake
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 3 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
MOM supplemented with PDM (group A)
VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM)
Intervention: donor human milk (Dietary Supplement)
MOM supplemented with TDM (group B)
VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM)
Intervention: donor human milk (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Soultana (Tania) Siahanidou
Professor in Pediatrics-Neonatology
National and Kapodistrian University of Athens