Mechanisms affecting the gut of preterm infants in enteral feeding trials: a nested cohort within a randomised controlled trial of lactoferrin

Accepted/In Press date: 25 October 2022

e-pub ahead of print date: 17 November 2022

Published date: 19 April 2023

Additional Information: Funding Information: JEB, NE and CS report grants to their institutions from Prolacta Biosciences US (Duarte, CA, USA), grants from Danone Early Life Nutrition (Paris, France) and personal fees from Nestlé Nutrition Institute (La Tour-de-Peilz, Switzerland). JD reports grants from the National Institute for Health Research (NIHR) during the conduct of the study and has been a member of the Health Technology Assessment (HTA) Efficient Study Designs; HTA Maternity, Newborn and Child Health (MNCH) Panel (2013-18); HTA General Board (2017-18); and HTA Post-Funding Committee teleconference. JD also reports grants from NIHR and Nutricia. Professor Juszczak reports grants from the National Institute for Health Research (NIHR) during the conduct of the study and was a member of the NIHR HTA General Board from (2016-17) and the HTA commissioning Board (2013-16). AKE reports grants from the NIHR. Funding Information: the MAGPIE study was funded by the Efficacy and Mechanistic Evaluation programme (EME) (Project Reference Number 13/122/02). The EME Programme is funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR). The Speed of Increases in Feeds Trial (SIFT) and the Enteral Lactoferrin in Neonates trial (ELFIN) were funded by the Health Technology Assessment programme of the UK NIHR. VLR also received PhD support from NECUK (registered charity 1181026). CL was an Academic Clinical Lecturer supported by the NIHR. The other authors received no additional funding. All funders did not participate in the work or have any influence on study design or conduct, data collection, management, interpretation of results, manuscript review or preparation. Funding Information: we gratefully acknowledge the research teams at individual recruiting sites (detailed online: https://doi.org/10.3310/eme08140 ), support from Chris Price and all the R&D department at Newcastle Hospitals NHS Trust, and all the parents who agreed for their baby to join the study. We acknowledge support from the NIHR Newcastle Biomedical Research Centre. We also gratefully acknowledge the members of the Trials Steering Committee: Professor Ben Stenson (chair), Professor Jonathan Wyllie, Dr Anne Dale and Ms Sharon McLeod (parent representative). Dr Anne Dale sadly died before this paper was published, and we would like to especially acknowledge her generosity in supporting our work. Mark Shirley and Steve Rushton (SNES, Newcastle University) aided in study design. Warwick Dunn and team (Phenome Centre, University of Birmingham) provided LCMS data of stool and urine. Darren Smith and Andrew Nelson (NUOMICS, Northumbria University) provided 16S rRNA sequencing data. © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.

Keywords: Intensive Care Units, Neonatal, Microbiology, Molecular Biology, Neonatology, Sepsis, Lactoferrin, Humans, Infant, Premature, Infant, Enteral Nutrition, Gestational Age, Infant, Newborn

Local EPrints ID: 485103

URI: http://eprints.soton.ac.uk/id/eprint/485103

DOI: doi:10.1136/archdischild-2022-324477

ISSN: 1359-2998

PURE UUID: 2c3b90e3-9895-47de-9f70-62a4c868dd14

ORCID for Jon Dorling: orcid.org/0000-0002-1691-3221

Date deposited: 29 Nov 2023 17:52

Last modified: 18 Mar 2024 04:16