Pasteurization of Mother's Own Milk for Preterm Infants

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580826
• Other study ID #: ML 3398
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: April 2012

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: April 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 2 Days

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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