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Lactoferrin Infant Feeding Trial - LIFT_Canada

NCT03367013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2024-11-29

No results posted yet for this study

Summary

This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants.

Conditions

  • Preterm Infant
  • Very Low Birth Weight Infant
  • Morbidity;Newborn

Interventions

DIETARY_SUPPLEMENT

Bovine Lactoferrin

Intervention includes a daily dose of 200 mg/kg bovine lactoferrin in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

OTHER

No Bovine Lactoferrin added

Control includes daily study feed with no bovine lactoferrin added in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.

Sponsors & Collaborators

  • Sunnybrook Research Institute (Toronto, Ontario)

    collaborator UNKNOWN

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Dr. Elizabeth Asztalos

    lead OTHER

Principal Investigators

  • Elizabeth Asztalos, MD,MSc,FRCPC · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Days
Max Age
7 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2022-07-27
Completion
2024-11-25

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03367013 on ClinicalTrials.gov