Lactoferrin Infant Feeding Trial - LIFT_Canada

Phase 3

Completed

• Conditions: Preterm Infant; Very Low Birth Weight Infant; Morbidity;Newborn
• Interventions: Dietary Supplement: Bovine Lactoferrin; Other: No Bovine Lactoferrin added

• Registration Number: NCT03367013
• Lead Sponsor: Dr. Elizabeth Asztalos

Brief 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.

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2018-02-22
• Primary Completion: 2022-07-27
• Status Verified: 2024-11
• Study Completion: 2024-11-25
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 453

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Bovine Lactoferrin	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.
Control Group	No Bovine Lactoferrin added	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.

Primary Outcome Measures

Name	Time	Method
Hospital mortality or major morbidity	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier.	Hospital mortality or major morbidity at 36 weeks corrected gestation defined as: * Brain injury on ultrasound; * Necrotizing enterocolitis (Bell stage II or higher ); * Late onset sepsis (≥ 72 hours of life, culture proven), or; Retinopathy of prematurity treated according to local guidelines before discharge from hospital.

Secondary Outcome Measures

Name	Time	Method
Incidence of chronic lung disease at 36 weeks CG	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Weight and head circumference at 36 weeks corrected gestation	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Time to first day of full enteral feeds (≥120ml/kg/day for 3 consecutive days)	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Number of blood transfusions	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Length of hospital stay	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Incidence of each of the 5 components of the composite primary endpoint	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier
Incidence of death by 24 months corrected age or the presence of neurodevelopmental outcomes at 24 months corrected age	Randomization to 36 weeks corrected gestation	Incidence of death by 24 months corrected age or the presence of major neurodevelopmental outcomes at 24 months corrected age, as defined: (i) visual (cannot fixate/ legally blind, or corrected acuity \<6/60 in both eyes), or hearing impairment (requiring a hearing aid or cochlear implants); (ii) cerebral palsy with an inability to walk unassisted; (iii) major developmental delay involving cognition or speech (composite score \< 85 for cognition or language on assessment)
Incidence of all-cause in-hospital mortality	Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier

Trial Locations

Locations (9)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Saint Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Health Sciences Centre Winnipeg; 🇨🇦 Winnipeg, Manitoba, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Children's and Women's Health Centre BC; 🇨🇦 Vancouver, British Columbia, Canada