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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prematurity

Intervention / Treatment
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* Dietary Supplement: donor human milk


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOM supplemented with PDM (group A)<br>VLBW Infants fed with mother's own milk (MOM) supplemented with preterm donor milk (PDM) | Dietary Supplement: donor human milk<br>* 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<br>|
| Active Comparator: MOM supplemented with TDM (group B)<br>VLBW infants fed with mother's own milk (MOM) supplemented with term donor milk (TDM) | Dietary Supplement: donor human milk<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preterm infants, nutrition, donor milk, breast milk