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

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.

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases Very Low Birth Weight

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Universitätsmedizin Berlin, Klinik für Neonatologie

Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm infants Birth weight below 1500g Admitted to Charité Universitätsmedizin Berlin Year of birth 2019-2024

Exclusion criteria

Major congenital malformations Chromosomal aberrations Known genetic conditions

Treatment and study plan

Primary outcomes

Severe Morbidity (NEC, Sepsis, BPD, ROP)

Time frame: up to 24 weeks or discharge from hospital, whatever occurs first

Necrotizing enterocolitis (requiring surgery), sepsis (blood culture-positive), bronchopulmonary dysplasia (requirement for oxygen supplementration at 36 weeks postmenstrual age), severe retinopathy (grade 3 or treatment with laser or intravitreal anti-VEGF agents)

Secondary outcomes

Duration of parenteral nutrition, duration of positive pressure ventilation, duration of supplemental oxygen, duration of hospitalization

Time frame: up to 24 weeks or discharge from hospital, whatever occurs first

interval between date of birth and date of elective cessation of measure

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: G-PAMINEO

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2026
First posted: Feb 17, 2026
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed