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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07411872
Acronym
G-PAMINEO
Enrollment
900
Registered
2026-02-17
Start date
2025-09-02
Completion date
2026-01-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity, Very Low Birth Weight

Keywords

milk pasteurization, cytomegalovirus, very low birth weight infants

Brief 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.

Interventions

None listed

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Severe Morbidity (NEC, Sepsis, BPD, ROP)up to 24 weeks or discharge from hospital, whatever occurs firstNecrotizing 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

MeasureTime frameDescription
Duration of parenteral nutrition, duration of positive pressure ventilation, duration of supplemental oxygen, duration of hospitalizationup to 24 weeks or discharge from hospital, whatever occurs firstinterval between date of birth and date of elective cessation of measure

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026