Impact of Sex and Own Mother's Milk Pasteurization on Morbidity and Mortality of Very Low Birth Weight Infants (G-PAMINEO)

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

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.

Study Overview

• Status: Completed
• Conditions: Prematurity; Very Low Birth Weight

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.

• Study Type: Observational
• Enrollment (Actual): 900

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Charité Universitätsmedizin Berlin, Klinik für Neonatologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Admitted to Charité Universitätsmedizin Berlin Year of birth 2019-2024

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Morbidity (NEC, Sepsis, BPD, ROP)	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)	up to 24 weeks or discharge from hospital, whatever occurs first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of parenteral nutrition, duration of positive pressure ventilation, duration of supplemental oxygen, duration of hospitalization	interval between date of birth and date of elective cessation of measure	up to 24 weeks or discharge from hospital, whatever occurs first

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cytomegalovirus; very low birth weight infants; milk pasteurization
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: EA2/170/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing requires prior consent of the Ethikkommission der Charité - Universitätsmedizin Berlin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No