Lactoferrin Infant Feeding Trial - LIFT_Canada

Dr. Elizabeth Asztalos

Status and phase: Completed; Phase 3

Conditions: Very Low Birth Weight Infant; Morbidity;Newborn; Preterm Infant

Treatments: Other: No Bovine Lactoferrin added; Dietary Supplement: Bovine Lactoferrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03367013

0890

Details and patient eligibility

About

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.

Full 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

Enrollment: 453 patients

Sex: All

Ages: 2 to 7 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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453 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Bovine Lactoferrin

Control Group

Sham Comparator group

Description:

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.

Treatment:

Other: No Bovine Lactoferrin added