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

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