Prematurity
Conditions
Keywords
preterm infants, nutrition, donor milk, breast milk
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.
Interventions
DIETARY_SUPPLEMENTdonor 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
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 3 Weeks
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of infants' growth | 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. |
| Assessment of protein intake | 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 | 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. |
Countries
Greece
Contacts
Primary ContactTania Siahanidou, MD, PhD
Backup ContactGiannoula Gialeli, MD
Outcome results
None listed