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Completed

NCT Number: NCT01580826

Pasteurization of Mother's Own Milk for Preterm Infants

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

1 day–2 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pasteurization of mother's own milk

Other

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

Other names: pasteurization

Primary outcomes

  1. incidence of late-onset sepsis

    Time frame: up to 8 weeks of age

    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 outcomes

  1. necrotizing enterocolitis

    Time frame: up to 8 weeks of age

    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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2012
First posted
Apr 19, 2012
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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