CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 453 enrolled
Drug / intervention
Bovine Lactoferrin +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03367013
NCT03367013Phase 3Completed
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Lactoferrin Infant Feeding Trial - LIFT_Canada

Dr. Elizabeth Asztalos·interventional·Posted Dec 8, 2017·Updated Nov 29, 2024

In Brief

A Phase 3 clinical trial evaluating Bovine Lactoferrin and No Bovine Lactoferrin added for Preterm Infant and 2 related conditions. Completed, enrolled 453 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPreterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
CountriesCanada
CollaboratorsSunnybrook Research Institute (Toronto, Ontario), Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedDec 8, 2017
Enrollment StartFeb 22, 2018
Primary CompletionJul 27, 2022
Study CompletionNov 25, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 8.6 years ago

Interventions

Bovine Lactoferrindietary

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.

No Bovine Lactoferrin addedother

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.