Pasteurization of Mother's Own Milk for Preterm Infants

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Sepsis

Treatments: Other: pasteurization of mother's own milk

Study type: Interventional

Funder types: Other

Identifiers

NCT01580826

ML 3398

Details and patient eligibility

About

We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.

Full description

In this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. The duration of the study is from birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need to ensure proper handling of the milk precludes true blinding of the caregivers. The institutional review board approved the study and written informed parental consent iss obtained before enrolment.

Enrollment: 303 patients

Sex: All

Ages: 1 to 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients born before 32 weeks of gestational age and/or with BW below 1500 g admitted to the tertiary NICU of the University Hospitals Leuven within 24 hours of birth

Exclusion criteria

• died within 24 hours after birth
• no consent
• admitted after 24 hours of birth

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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303 participants in 2 patient groups

raw milk

No Intervention group

Description:

Infants who were assigned to the raw group received fresh or thawed milk from their own mother, cultured weekly with a semi-quantitative analysis. Raw milk was withheld if it contained any Gram-negative organisms, S. aureus or enterococci.

pasteurized milk

Active Comparator group

Description:

Infants who were assigned to pasteurization received own mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.

Treatment:

Other: pasteurization of mother's own milk