Status:
COMPLETED
Lactoferrin Infant Feeding Trial - LIFT_Canada
Lead Sponsor:
Dr. Elizabeth Asztalos
Collaborating Sponsors:
Sunnybrook Research Institute (Toronto, Ontario)
Canadian Institutes of Health Research (CIHR)
Conditions:
Preterm Infant
Very Low Birth Weight Infant
Eligibility:
All Genders
2-7 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2024
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT03367013
Start Date
February 22 2018
End Date
November 25 2024
Last Update
November 29 2024
Active Locations (9)
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1
Foothills Medical Centre
Calgary, Alberta, Canada
2
Children's and Women's Health Centre BC
Vancouver, British Columbia, Canada
3
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada
4
Saint Boniface Hospital
Winnipeg, Manitoba, Canada