Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: donor human milk.
- Who it may be relevant to
- Registry conditions: Prematurity. Basic parameters: 1 Day — 3 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
Overview
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.
Interventions
- 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
Primary outcome measures
- Assessment of infants' growth [Time frame: 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)]
- Assessment of morbidity [Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Greece · 2 centers
- Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital — Athens
- First Department of Pediatrics, National and Kapodistrian University of Athens — Athens
Publications
- 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 36771273
Identifiers
NCT: NCT05675397 · 6116