Pasteurization of Mother's Own Milk for Preterm Infants

Study Overview
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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.

Official Title
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Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.

Conditions
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Sepsis

Intervention / Treatment
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* Other: pasteurization of mother's own milk


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: raw milk<br>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. | |
| Active Comparator: pasteurized milk<br>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. | Other: pasteurization of mother's own milk<br>* mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.<br>* Other names: pasteurization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of late-onset sepsis | 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). | up to 8 weeks of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necrotizing enterocolitis | 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. | up to 8 weeks of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pasteurization, human milk, very low birth weight infants