Protocol for the Lactoferrin Infant Feeding Trial (LIFT) : A randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge

Journal article


Martin, Andrew, Ghadge, Alpana, Manzoni, Paolo, Lui, Kei, Brown, Rebecca and Tarnow-Mordi, William. (2018). Protocol for the Lactoferrin Infant Feeding Trial (LIFT) : A randomised trial of adding lactoferrin to the feeds of very-low birthweight babies prior to hospital discharge. BMJ Open. 8(10), p. Article: e023044. https://doi.org/10.1136/bmjopen-2018-023044
AuthorsMartin, Andrew, Ghadge, Alpana, Manzoni, Paolo, Lui, Kei, Brown, Rebecca and Tarnow-Mordi, William
Abstract

Introduction Very-low birthweight (VLBW, <1500 g) infants comprise about 1%–1.4% of all births in high-income countries. Every year, about 3000 VLBW babies in Australia and New Zealand receive intensive care. Many die or else survive with severe brain injury, retinopathy, late-onset sepsis or necrotising enterocolitis (NEC), each of which carries substantial risk of disability.

Methods and analysis This trial tests whether adding bovine lactoferrin (bLF) to feeds in VLBW infants improves (1) survival to hospital discharge free from brain injury, late-onset sepsis, NEC and treated retinopathy of prematurity (primary composite end point); (2) each component of the primary composite end point and (3) time to reach full enteral feeds, number of blood transfusions, chronic lung disease and length of hospital stay. It includes a cost-effectiveness analysis of bLF in improving survival free from major morbidity, and evaluates the effect of bLF on survival and developmental outcomes at 24 to 36 months corrected gestational age.

This is a multicentre, two-arm, randomised trial comparing the treatment group receiving bLF added to breast milk or formula milk daily (up to 250 mg/kg/day bLF) versus the control group receiving no bLF supplementation. The intervention is administered until 34 completed weeks corrected gestation or for 2 weeks, whichever is longer, or until discharge home, if earlier. The target sample size of 1500 participants yields 85% power, at the two-sided 5% level significance, to detect a difference in proportions meeting the primary outcome assuming the true probability is 74% in controls and 80.5% in the bLF group.

Ethics and dissemination This protocol was approved by Northern Sydney Local Human Research Ethics Committee in January 2017 (Version 2.0, Reference 1003-118M) and other relevant ethics committees. The findings of the trial will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number ACTRN12611000247976; Pre-results.

Year2018
JournalBMJ Open
Journal citation8 (10), p. Article: e023044
PublisherB M J Group
ISSN2044-6055
Digital Object Identifier (DOI)https://doi.org/10.1136/bmjopen-2018-023044
PubMed ID30282685
Scopus EID2-s2.0-85054424083
PubMed Central IDPMC6169746
Research or scholarlyResearch
Page range1-8
FunderNational Health and Medical Research Council (NHMRC)
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online02 Oct 2018
Publication process dates
Accepted19 Jun 2018
Deposited08 Nov 2021
Grant IDNHMRC/1047100
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License: CC BY-NC 4.0
File access level: Open

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