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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

Lactoferrin Infant Feeding Trial - LIFT_Canada

Clinicaltrials.gov identifier NCT03367013

Recruitment Status Recruiting

First Posted December 8, 2017

Last update posted June 2, 2020

Study Description

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.

  • Condition or Disease:Preterm Infant
    Very Low Birth Weight Infant
    Morbidity;Newborn
  • Intervention/Treatment: Dietary Supplement: Bovine Lactoferrin
    Other: No Bovine Lactoferrin added
  • Phase: Phase 3
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

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 500 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention
  • Official Title: Lactoferrin Infant Feeding Trial - LIFT_Canada
  • Actual Study Start Date: February 2018
  • Estimated Primary Completion Date: July 2021
  • Estimated Study Completion Date: September 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Intervention Group
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.
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.
Sham Comparator: Control Group
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.
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.
Outcome Measures
  • Primary Outcome Measures: 1. Hospital mortality or major morbidity [ Time Frame: 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: 1. Time to first day of full enteral feeds (≥120ml/kg/day for 3 consecutive days) [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 2. Incidence of all-cause in-hospital mortality [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 3. Incidence of each of the 5 components of the composite primary endpoint [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 4. Incidence of chronic lung disease at 36 weeks CG [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 5. Number of blood transfusions [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 6. Length of hospital stay [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 7. Weight and head circumference at 36 weeks corrected gestation [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  • 8. Incidence of death by 24 months corrected age or the presence of neurodevelopmental outcomes at 24 months corrected age [ Time Frame: 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)
Eligibility Criteria
  • Ages Eligible for Study: up to 7 / (Birth to 17 years)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

An infant will be able to participate once a parent or guardian has provided a written
informed consent and the infants must meet all of the following inclusion criteria:

- <1500 g at birth - 2-7 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

Contacts and Locations
Contacts

Contact: Elizabeth Asztalos, MD,MSc,FRCPC 416-4806100 ext 87791 elizabeth.asztalos@sunnybrook.ca

Contact: Afsheen Ayaz, MBBS,MSc,CCRP 416-4806100 ext 87994 afsheen.ayaz@sunnybrook.ca

Locations

Canada, Manitoba
Health Sciences Centre Winnipeg
Winnipeg

Canada, Manitoba
Saint Boniface Hospital
Winnipeg

Canada, Nova Scotia
IWK Health Centre
Halifax

Canada, Ontario
McMaster Children's Hospital
Hamilton

Canada, Ontario
The Ottawa Hospital
Ottawa

Canada, Ontario
Mount Sinai Hospital
Toronto

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto

Sponsors and Collaborators

Sunnybrook Health Sciences Centre

Canadian Institutes of Health Research (CIHR)

National Health and Medical Research Council, Australia

Investigators

Principal Investigator: Elizabeth Asztalos, MD,MSc,FRCPC Sunnybrook Health Sciences Centre

More Information