CompletedPhase 3

Lactoferrin Infant Feeding Trial - LIFT_Canada

Canada453 participantsStarted 2018-02-22

Plain-language 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.

Who can participate

Age range2 Days – 7 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hospital mortality or major morbidity

Timeframe: Randomization to 36 weeks corrected gestation or to transfer/discharge if earlier.

Trial details

NCT IDNCT03367013

SponsorDr. Elizabeth Asztalos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-27

View on ClinicalTrials.gov More Preterm Infant trials