Pasteurization of Mother's Own Milk for Preterm Infants

NCT01580826 | Completed DMC

• 1 other identifier: ML 3398
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis

Keywords

pasteurization; human milk; very low birth weight infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• necrotizing enterocolitis

  up to 8 weeks of age

Study Arms (2)

raw milk

NO INTERVENTION

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.

pasteurized milk

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: pasteurization

pasteurized milk

Eligibility Criteria

• Age: 1 Day - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• died within 24 hours after birth
• no consent
• admitted after 24 hours of birth

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Sepsis

Interventions

Pasteurization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food Handling; Food Industry; Industry; Technology, Industry, and Agriculture; Food Preservation; Food Technology

Study Officials

• Veerle Cossey, Dr

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicpal Investigator

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 19, 2012
• Study Start: March 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2012
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

BE (1)