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Paediatrics
Protocol
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
  1. Andrew Martin1,
  2. Alpana Ghadge1,
  3. Paolo Manzoni2,
  4. Kei Lui3,4,
  5. Rebecca Brown1,
  6. William Tarnow-Mordi1
  7. for the LIFT Collaborative Study Group
    1. 1 NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia
    2. 2 S. Anna Hospital Torino, Torino, Italy
    3. 3 Department of Newborn Care, Royal Hospital for Women, Randwick, New South Wales, Australia
    4. 4 School of Women’s and Children’s Health, University of New South Wales, Kensington, New South Wales, Australia
    1. Correspondence to Dr William Tarnow-Mordi; williamtm{at}med.usyd.edu.au

    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.

    • lactoferrin
    • infant, premature
    • sepsis
    • Enterocolitis, necrotizing

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

    https://doi.org/10.1136/bmjopen-2018-023044

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      Footnotes

      • Contributors WT-M, KL, AM and PM conceived of and designed the study. WT-M, AM, PM, AG and KL acquired the funding. AG and RB coordinated the implementation of the study and the acquisition of data. AM and WT-M drafted the manuscript. All authors (AM, AG, PM, KL, RB, WT-M) revised the manuscript critically for important intellectual content and approved the final version.

      • Funding This work is supported by the National Health and Medical Research Council (grant no: APP1047100).

      • Competing interests None declared.

      • Patient consent Not required.

      • Ethics approval Northern Sydney Local Human Research Ethics Committee in January 2017 (Version 2.0, Reference 1003-118M); Australian Capital Territory Human Research Ethics Committee in March 2017 (Version 2.0, Reference ETH.6.14.140); Women’s and Children’s Health Network Human Research Ethics Committee in March 2017 (Version 2.0, Reference HREC/13/WCHN/165); Mercy Health Human Research Ethics Committee in June 2017 (Version 2.0, Reference R16/19); Northern B Health and Disability Ethics Committee in January 2018 (Version 2.0, Reference 16/NTB/12/AM04).

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators LIFT Collaborative Study Group Trial Management Committee: William Tarnow-Mordi; John Simes; Wendy Hague; Alpana Ghadge; Kei Lui; David Osborn; Girish Deshpande; Anu Kochar; Tony Lewis; Andrew Watkins; Margo Pritchard; Deborah Schofield; Abdel Latif Mohamed; Andrew Martin; Chief Investigators: William Tarnow-Mordi; Roger Soll; Paolo Manzoni; Brian Darlow; David Isaacs; Kei Lui; Deborah Schofield; Dominic Wilkinson; Andrew Martin; Wendy Hague; Associate Investigators: Alicia Wood; Anne McKenzie; Girish Despande; Hannah Verry; Ian Wright; John Simes; Lisa Askie; Melinda Cruz; Nina Berry; William McGuire; Site Investigators/Coordinators: Abdel Latif Mohamed; Marg Broom; David Osoborn; Shelley Reid; John Sinn; Peggy Kwan; Mark Tracy; Carol Hua; Javeed Travadi; Ros Black; Rodney Tobiansky; Dianne Darcy/Suk Ngor Honvi Tai; Kei Lui; Jo Michalowski; Girsh Deshpande; Archana Bhaskaracharya; Tony Lewis; Emma Yeomans/Kristy Elsayed; Clare Collins; Elizabeth Noble; Pieter Koorts; Gill Lack/Lisa McKeown; Helen Liley; Wenjun Nie; Scott Morris; Kathy Cornthwaite; Anu Kochar; Louise Goodchild; Nicola Austin; Trisha Graham; Harshad Patel; Dorothy Sanchez; Independent Data Safety Monitoring Committee: Chris McKinlay; Neena Modi; Ian Marschner; Ben Stenson; David Espinoza (unblinded statistician, nonvoting).