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Lactoferrin Infant Feeding Trial - LIFT_Canada

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ClinicalTrials.gov Identifier: NCT03367013
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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 Intervention/treatment Phase
Preterm Infant Very Low Birth Weight Infant Morbidity;Newborn Dietary Supplement: Bovine Lactoferrin Other: No Bovine Lactoferrin added 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 Type : Interventional  (Clinical Trial)
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 16, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 30, 2022

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.
Other Name: Lactoferrin-250

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.




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
    • Chronic lung disease
    • 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. Incidence of all-cause in-hospital mortality [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  2. 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 ]
  3. 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 ]
  4. Number of blood transfusions [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  5. Length of hospital stay [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  6. Weight and head circumference at 36 weeks corrected gestation [ Time Frame: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier ]
  7. Incidence of death by 24 months corrected age or the presence of major 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)



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Ages Eligible for Study:   up to 7 Days   (Child)
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367013


Contacts
Contact: Elizabeth Asztalos, MD,MSc,FRCPC 416-4806100 ext 87791 elizabeth.asztalos@sunnybrook.ca
Contact: Afsheen Ayaz, MBBS,MSc 416-4806100 ext 87994 afsheen.ayaz@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Afsheen Ayaz, MBBS,MSc.    416-480-6100 ext 87994    afsheen.ayaz@sunnybrook.ca   
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

Additional Information:
Publications:
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03367013     History of Changes
Other Study ID Numbers: 0890
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Lactoferrin
Anti-Infective Agents