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Pasteurization of Mother's Own Milk for Preterm Infants

NCT ID: NCT01580826

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis

Keywords

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pasteurization human milk very low birth weight infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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raw milk

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

pasteurized milk

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.

Group Type ACTIVE_COMPARATOR

pasteurization of mother's own milk

Intervention Type OTHER

mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.

Interventions

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pasteurization of mother's own milk

mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.

Intervention Type OTHER

Other Intervention Names

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pasteurization

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Dr. Veerle Cossey

Prinicpal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veerle Cossey, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML 3398

Identifier Type: -

Identifier Source: org_study_id