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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03367013
Recruitment Status Recruiting
First Posted December 8, 2017
Last update posted June 2, 2020
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.
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
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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
Contact: Elizabeth Asztalos, MD,MSc,FRCPC 416-4806100 ext 87791 email@example.com
Contact: Afsheen Ayaz, MBBS,MSc,CCRP 416-4806100 ext 87994 firstname.lastname@example.org
Health Sciences Centre Winnipeg
Saint Boniface Hospital
Canada, Nova Scotia
IWK Health Centre
McMaster Children's Hospital
The Ottawa Hospital
Mount Sinai Hospital
Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Principal Investigator: Elizabeth Asztalos, MD,MSc,FRCPC Sunnybrook Health Sciences Centre
Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS, Whitfield MF; Trial of Indomethacin Prophylaxis in Preterms (TIPP) Investigators. Impact of bronchopulmonary dysplasia, brain injury, and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms. JAMA. 2003 Mar 5;289(9):1124-9.
Bassler D, Stoll BJ, Schmidt B, Asztalos EV, Roberts RS, Robertson CM, Sauve RS; Trial of Indomethacin Prophylaxis in Preterms Investigators. Using a count of neonatal morbidities to predict poor outcome in extremely low birth weight infants: added role of neonatal infection. Pediatrics. 2009 Jan;123(1):313-8. doi: 10.1542/peds.2008-0377.
Schulzke SM, Deshpande GC, Patole SK. Neurodevelopmental outcomes of very low-birth-weight infants with necrotizing enterocolitis: a systematic review of observational studies. Arch Pediatr Adolesc Med. 2007 Jun;161(6):583-90. Review.