NCT07411872

Impact of Sex and Own Mother's Milk Pasteurization on Morbidity and Mortality of Very Low Birth Weight Infants

Einfluss Von Geschlecht Und Pasteurisierung Auf Das Neonatale Outcome Bei Frühgeborenen Unter 1.500 g: Retrospektive Analyse Zur Bedeutung Der Muttermilch

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 900 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

In very low birth weight (\<1500g) preterm infants, nutrition with mother's own milk, as opposed to formula, is associated with reduced morbidity and mortality. At present, the merits and risks of pasteurising mother's own milk (recommended if the mother is positive for cytomegalovirus) are unknown. This single-institution retrospective analysis aims at comparing mortality and morbidity of preterm infants below 1500g birth weight who were fed raw (unpasteurized) or pasteurized mother's own milk (in case the mother is positive for cytomegalovirus). The infant's sex into is taken into account as a possible confounder.

Detailed description

Retrospective analysis of preterm infants below 1500g birth admitted 2019-2024 to the Department of Neonatology at the Charité - Universitätsmedizin Berlin. Infants with major congenital malformation, chromosomal aberrrations and known genetic conditions are excluded. Input variables are basic demographic data (gestational age, birth weight, sex, antenatal steroids, and others), duration of mother's own milk feeding, duration of donor milk feeding, cytomegalovirus status of the mother, pasteurization of mother's own milk (start and end date), main outcome variables are death, major surgery, necrotizing enterocolitis, duration of antibiotic treatment, duration of positive pressure ventilation, duration of oxygen supplementation, duration of hospital treatment.

Conditions

• Prematurity
• Very Low Birth Weight

Timeline

• Start date: 2025-09-02
• Primary completion: 2025-12-31
• Completion: 2026-01-30
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: Germany