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Pasteurization of Mother's Own Milk for Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Veerle Cossey, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01580826
First received: April 18, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Sepsis
 Other: pasteurization of mother's own milk

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • incidence of late-onset sepsis [ Time Frame: up to 8 weeks of age ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • necrotizing enterocolitis [ Time Frame: up to 8 weeks of age ] [ Designated as safety issue: No ]
    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.


Enrollment: 303
Study Start Date: March 2006
Study Completion Date: April 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Other: pasteurization of mother's own milk
mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
Other Name: pasteurization
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.
 Other: pasteurization of mother's own milk
mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
Other Name: pasteurization

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.

  Eligibility

Ages Eligible for Study:   up to 2 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01580826

Locations
Belgium
University Hospitals
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Veerle Cossey, Dr Universitaire Ziekenhuizen Leuven
  More Information

No publications provided

Responsible Party: Dr. Veerle Cossey, Prinicpal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01580826     History of Changes
Other Study ID Numbers: ML 3398
Study First Received: April 18, 2012
Last Updated: April 18, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
pasteurization
human milk
very low birth weight infants

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013