Lactoferrin Infant Feeding Trial - LIFT_Canada

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    500
  • sponsor
    Sunnybrook Health Sciences Centre
Updated on 4 March 2022

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.

Description

Almost 3,000 very low birth weight (VLBW), <1500g preterm infants are born and treated in Canada annually. About 1,200 either die or survive with severe brain or lung injury, retinopathy, late-onset sepsis or necrotizing enterocolitis (NEC), each of which is associated with substantial risk of childhood disability.

Lactoferrin is an antimicrobial, antioxidant, anti-inflammatory iron-carrying, bifidogenic glycoprotein found in all vertebrates and in mammalian milk, leukocytes and exocrine secretions. However, most VLBW infants receive insufficient human lactoferrin (hLF) from human breast milk in the first months of life, resulting in suboptimal protection. Because hLF is expensive, bovine lactoferrin (bLF) has been considered as an alternate supplement to improve this suboptimal protection.

LIFT is one of several ongoing trials using higher doses of bovine bLF in the VLBW population (120-200 mg/kg/d). If LIFT confirms a 19% reduction in the relative risk of its primary outcome, bLF will have a major impact, translating into thousands more intact survivors without major morbidity in Australia, New Zealand, Canada, Europe and worldwide each year. As >90% of very preterm survivors at hospital discharge reach adulthood, this represents more than 19,000 life-years gained in Canada alone each year, one of the largest gains in intact survival in any specialty since neonatal surfactant and antenatal steroids

Details
Condition Preterm Infant, Very Low Birth Weight Infant, Morbidity;Newborn
Treatment Bovine lactoferrin, No Bovine Lactoferrin added
Clinical Study IdentifierNCT03367013
SponsorSunnybrook Health Sciences Centre
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

<1500 g at birth
-7 days old and not moribund
infant is considered to be stable by the clinical care team
has initiated feeds
Any infant meeting any of the following exclusion criteria will be excluded
from participation in this study
severe congenital anomalies which are likely to cause death or known to contribute to an adverse neurodevelopmental outcome
major congenital gastrointestinal anomalies which will prevent an early approach to feeding
parents unable to provide informed consent
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