Clinical trial NCT05675397: Preterm Donor Human Milk Supplementation of Mother's Own Milk in VLBW Infants
Official title: Supplementation of Mother's Own Milk With Preterm Donor Human Milk: Impact on Morbidity and Growth in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity
Keywords: preterm infants
nutrition
donor milk
breast milk
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Assessment of infants' growth
timeFrame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
measure: Assessment of protein intake
timeFrame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
measure: Assessment of morbidity
timeFrame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
city: Athens
country: Greece
facility: First Department of Pediatrics, National and Kapodistrian University of Athens
Study officials:
affiliation: Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
name: George Liosis, MD, PhD
role: STUDY_CHAIR
affiliation: Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital, Athens, 11521, Greece
name: Giannoula Gialeli
role: PRINCIPAL_INVESTIGATOR
affiliation: First Department of Pediatrics, School of Medicine, National and Kapodistrian University of Athens
name: Tania Siahanidou
role: STUDY_DIRECTOR
References: