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Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants

Dorling, Jon; Abbott, Jane; Berrington, Janet; Bosiak, Beth; Bowler, Ursula; Boyle, Elaine; Embleton, Nicholas; Hewer, Oliver; Johnson, Samantha; Juszczak, Edmund; Leaf, Alison; Linsell, Louise; McCormick, Kenny; McGuire, William; Omar, Omar; Partlett, Christopher; Patel, Mehali; Roberts, Tracy; Stenson, Ben; Townend, John

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Authors

Jon Dorling

Jane Abbott

Janet Berrington

Beth Bosiak

Ursula Bowler

Elaine Boyle

Nicholas Embleton

Oliver Hewer

Samantha Johnson

Alison Leaf

Louise Linsell

Kenny McCormick

William McGuire

Omar Omar

CHRIS PARTLETT Chris.Partlett@nottingham.ac.uk
Assistant Professor of Medical Statistics and Clinical Trials

Mehali Patel

Tracy Roberts

Ben Stenson

John Townend



Abstract

Background
Observational data have shown that slowly advancing enteral feeds in preterm infants is associated with reduced risk for necrotizing enterocolitis but increased risk for late onset sepsis. However, randomized trial data are limited.
Methods
We randomized very preterm or very low birthweight (VLBW) infants to daily milk increments of 30 or 18ml/kg/day until reaching full feeds. The primary outcome was survival without moderate or severe neurodevelopmental disability at 24 months. Secondary outcomes included components of the primary outcome, confirmed or suspected late onset sepsis, necrotizing enterocolitis and cerebral palsy.
Results
Among 2,804 infants randomized, the primary outcome was classifiable in 1224 (87.4%) of infants allocated to faster and 1246 (88.7%) to slower increments. Survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802/1224 (65.5%) of infants allocated to faster and 848/1246 (68.1%) allocated to slower increments (adjusted risk ratio (RR), 0.96; 95% Confidence interval (CI), 0.92 to 1.01; p=0.16). Late onset sepsis occurred in 414/1389 (29.8%) of the faster and 434/1397 (31.1%) of the slower increment group (adjusted RR 0.96; 95% CI 0.86 to 1.07). Necrotizing enterocolitis occurred in 70/1394 (5.0%) of the faster and 78/1399 (5.6 %) of the slower group (adjusted RR 0.88; 95% CI, 0.68 to 1.16).
Conclusions
There was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months in very preterm or VLBW infants with a strategy of advancing milk feeds in daily increments of 30ml/kg versus 18ml/kg.
(Funded by the Health Technology Assessment Programme of the National Institute for Health Research; ISRCTN registration number ISRCTN76463425).

Citation

Dorling, J., Abbott, J., Berrington, J., Bosiak, B., Bowler, U., Boyle, E., …Townend, J. (2019). Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants. New England Journal of Medicine, 381(15), 1434-1443. https://doi.org/10.1056/NEJMoa1816654

Journal Article Type Article
Acceptance Date Jun 17, 2019
Online Publication Date Oct 10, 2019
Publication Date Oct 10, 2019
Deposit Date Aug 21, 2019
Publicly Available Date Apr 11, 2020
Journal New England Journal of Medicine
Print ISSN 0028-4793
Electronic ISSN 1533-4406
Publisher Massachusetts Medical Society
Peer Reviewed Peer Reviewed
Volume 381
Issue 15
Pages 1434-1443
DOI https://doi.org/10.1056/NEJMoa1816654
Public URL https://nottingham-repository.worktribe.com/output/2454326
Publisher URL https://www.nejm.org/doi/full/10.1056/NEJMoa1816654

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