- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01580826
Pasteurization of Mother's Own Milk for Preterm Infants
November 29, 2023 updated by: Dr. Veerle Cossey, Universitaire Ziekenhuizen KU Leuven
Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
303
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leuven, Belgium, 3000
- University Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 2 days (Child)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
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mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
Other Names:
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Active Comparator: 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.
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mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of late-onset sepsis
Time Frame: up to 8 weeks of age
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the incidence of proven late-onset sepsis, occurring more than 48 hours after birth, with growth of a pathogen or coagulase-negative staphylococci (CoNS) cultured from blood, obtained from a peripheral vein under aseptic conditions, combined with the acute onset of two or more predefined clinical signs and, only in case of growth of a CoNS isolate, at least one laboratory parameter of systemic infection (such as elevated C-reactive protein, left shift or leukopenia).
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up to 8 weeks of age
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
necrotizing enterocolitis
Time Frame: up to 8 weeks of age
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Secondary end points were the incidence of clinical sepsis ; infection site other than bloodstream; the antibiotic utilization rate ; necrotizing enterocolitis stages II and III ; intraventricular hemorrhage or periventricular leucomalacia; need of respiratory support; chronic lung disease ; severe retinopathy of prematurity; the length of NICU stay for survivors and in-NICU mortality.
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up to 8 weeks of age
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Veerle Cossey, Dr, Universitaire Ziekenhuizen KU Leuven
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
April 18, 2012
First Submitted That Met QC Criteria
April 18, 2012
First Posted (Estimated)
April 19, 2012
Study Record Updates
Last Update Posted (Estimated)
December 6, 2023
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- ML 3398
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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