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Dietary Supplement

Bovine Lactoferrin for Very Low Birth Weight in Premature Infants

Phase 3
Waitlist Available
Led By Elizabeth Asztalos, MD,MSc,FRCPC
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infant must be <1500 g at birth
Infant must be 2-7 days old and not moribund
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization to 36 weeks corrected gestation
Awards & highlights

Study Summary

This trial is testing whether bovine lactoferrin can reduce mortality or major morbidity in very low birth weight preterm infants.

Who is the study for?
The LIFT_Canada trial is for very low birth weight preterm infants who are stable, between 2-7 days old, have started feeding, and weigh less than 1500 grams at birth. Infants with severe congenital anomalies or major gastrointestinal issues that affect feeding cannot participate.Check my eligibility
What is being tested?
This study tests if adding bovine lactoferrin to the diets of premature babies can reduce death or serious illness by using its antimicrobial and anti-inflammatory effects. Babies in the trial will be randomly assigned to receive either bovine lactoferrin or no supplement.See study design
What are the potential side effects?
As a natural protein found in milk, bovine lactoferrin is expected to be safe for infants. However, potential side effects may include allergic reactions or intolerance specific to individual babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby weighed less than 1500 grams at birth.
Select...
My baby is between 2-7 days old and not at risk of dying.
Select...
My infant has started feeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization to 36 weeks corrected gestation
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to 36 weeks corrected gestation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hospital mortality or major morbidity
Secondary outcome measures
Incidence of all-cause in-hospital mortality
Incidence of chronic lung disease at 36 weeks CG
Incidence of death by 24 months corrected age or the presence of neurodevelopmental outcomes at 24 months corrected age
+5 more

Side effects data

From 2018 Phase 2 trial • 55 Patients • NCT01830595
2%
Cough, congestion, sinus pressure, fatigue
2%
Hospitalized for syncope episode
2%
Bone spur on spine
2%
surgery on rotator cuff
2%
torn rotator cuff
2%
Depression
2%
Elevated CK
2%
Bone
2%
Fatigue, cough and sore throat
2%
tinnitus
2%
right leg pain
2%
Upper Respiratory infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Lactoferrin
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment1 Intervention
The intervention group will receive a daily dose of 200 mg/kg of 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.
Group II: Control GroupPlacebo Group1 Intervention
The control group will receive 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bovine Lactoferrin
2020
Completed Phase 3
~940

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,333 Previous Clinical Trials
25,746,905 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
165 Previous Clinical Trials
474,684 Total Patients Enrolled
Sunnybrook Health Sciences CentreLead Sponsor
651 Previous Clinical Trials
1,542,236 Total Patients Enrolled

Media Library

Bovine Lactoferrin (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03367013 — Phase 3
Very Low Birthweight Research Study Groups: Intervention Group, Control Group
Very Low Birthweight Clinical Trial 2023: Bovine Lactoferrin Highlights & Side Effects. Trial Name: NCT03367013 — Phase 3
Bovine Lactoferrin (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03367013 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we able to enroll people who are below the age of 40 in this clinical trial?

"For this particular trial, only patients between the age of 2 days to 7 days qualify. Out of the 81 clinical trials taking place, 64 are for patients under 18 years old and 17 are for patients over 65 years old."

Answered by AI

How many different locations are testing this out?

"This study has 8 active locations, with 3 being Children's and Women's Health Centre BC in Vancouver, The Ottawa Hospital in Ottawa, and IWK Health Centre in Halifax."

Answered by AI

Has Bovine Lactoferrin been cleared by the FDA?

"Bovine Lactoferrin is a medication that has been studied in multiple Phase 3 clinical trials. This suggests that while there is some data supporting its efficacy, there is extensive data demonstrating its safety. As such, our team has rated the safety of Bovine Lactoferrin as a 3."

Answered by AI
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~64 spots leftby Mar 2025