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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
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
Neonatal Intensive Care Unit, "Elena Venizelou" General and Maternal Hospital
Athens, Greece
RECRUITINGFirst Department of Pediatrics, National and Kapodistrian University of Athens
Athens, Greece
NOT_YET_RECRUITINGAssessment of infants' growth
Infants' weight gain during hospitalization (grams per day) will be assessed and compared between group A and group B.
Time frame: 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.
Time frame: 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.
Time frame: From randomization to discharge, up to 40 weeks of postconceptional age (term equivalent age)
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