LIFT Trial Information
Lactoferrin Infant Feeding Trial
- To test the hypothesis that adding bovine lactoferrin (bLF) to feeds in preterm babies of less than 1500 g birth weight will (i) improve survival free from major hospital morbidity (primary composite endpoint); and, (ii) have a beneficial effect on each component of the composite primary endpoint, as well as the number of blood transfusions given, length of hospital stay, time to full enteral feeds and growth to 36 weeks gestation.
- To conduct a Cost Effectiveness Analysis of bLF in improving survival free from major hospital morbidity (in Australia only).
- To evaluate the effect of bLF on survival and developmental outcomes at 24 and 36 months corrected gestational age.
Multicentre 2-arm, randomised controlled trial.
Babies with birth weight less than 1500g and less than 7days old.
The two arms of the trial comprise:
a. Treatment group: bLF added to breast milk or formula milk once daily
b. Control group: no bLF added to breast milk or formula milk
Study intervention is administered until 34 weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier.
Primary outcome: Survival free from (i) 4 morbidities diagnosed or treated in hospital by 36 weeks corrected gestational age: brain injury or chronic lung disease or late onset sepsis or necrotising
enterocolitis (NEC) and from (ii) retinopathy treated according to local guidelines up to discharge from hospital.
Secondary outcomes: Survival; survival without sepsis; brain injury; chronic lung disease; retinopathy treated according to local guidelines up to discharge, late onset sepsis diagnosed 48 hours after birth, NEC diagnosed or treated in hospital by 36 weeks corrected gestational age, time to full enteral feeds, number of blood transfusions, length of hospital stay, growth to 36 weeks gestation, survival and development outcomes at 24 and 36 months corrected gestational age.
1,100 infants yields >80% power to show an improvement in relative risk (RRR) of the primary outcome, from 68% in controls to 76 % in infants having bLF, at 2p = 0.05.
Consistency of the treatment effect on the primary endpoint will be evaluated across the following subgroups:
a. birth-weight <1000 g and 1000-1499 g;
b. randomised ≤72 hr and >72 hr from birth;
c. those who received or did not receive probiotics;
d. ≤ 28 weeks and >28 weeks gestation
Investigators and primary contacts
Principal Investigator: Professor William Tarnow Mordi, University of Sydney
Project Manager: Dr Alpana Ghadge
Project Statistician: Dr Andrew Martin
Coordinating Centre: NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown NSW 1450
Australia New Zealand Clinical Trials Registry (ANZCTR) Trial Registry Number: