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Randomized Controlled Trial Multicenter Study Comparative Study
Controlled Trial of Two Incremental Milk-Feeding Rates in Preterm Infants.
- Jon Dorling, Jane Abbott, Janet Berrington, Beth Bosiak, Ursula Bowler, Elaine Boyle, Nicholas Embleton, Oliver Hewer, Samantha Johnson, Edmund Juszczak, Alison Leaf, Louise Linsell, Kenny McCormick, William McGuire, Omar Omar, Christopher Partlett, Mehali Patel, Tracy Roberts, Ben Stenson, John Townend, and SIFT Investigators Group.
- From the Division of Neonatal-Perinatal Medicine, Dalhousie University, Halifax, NS, Canada (J.D.); and Bliss, London (J.A., M.P.), the National Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford (B.B., U.B., O.H., E.J., L.L., O.O., C.P., J.T.), and John Radcliffe Hospital (K.M.), Oxford, the Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne (J.B., N.E.), the Department of Health Sciences, University of Leicester, Leicester (E.B., S.J.), the National Institute for Health Research Southampton Biomedical Research Centre, Department of Child Health, Southampton (A.L.), the Centre for Reviews and Dissemination, University of York, York (W.M.), the School of Health and Population Sciences, University of Birmingham, Birmingham (T.R.), and the Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh (B.S.) - all in the United Kingdom.
- N. Engl. J. Med. 2019 Oct 10; 381 (15): 1434-1443.
BackgroundObservational data have shown that slow advancement of enteral feeding volumes in preterm infants is associated with a reduced risk of necrotizing enterocolitis but an increased risk of late-onset sepsis. However, data from randomized trials are limited.MethodsWe randomly assigned very preterm or very-low-birth-weight infants to daily milk increments of 30 ml per kilogram of body weight (faster increment) or 18 ml per kilogram (slower increment) until reaching full feeding volumes. 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.ResultsAmong 2804 infants who underwent randomization, the primary outcome could be assessed in 1224 (87.4%) assigned to the faster increment and 1246 (88.7%) assigned to the slower increment. Survival without moderate or severe neurodevelopmental disability at 24 months occurred in 802 of 1224 infants (65.5%) assigned to the faster increment and 848 of 1246 (68.1%) assigned to the slower increment (adjusted risk ratio, 0.96; 95% confidence interval [CI], 0.92 to 1.01; P = 0.16). Late-onset sepsis occurred in 414 of 1389 infants (29.8%) in the faster-increment group and 434 of 1397 (31.1%) in the slower-increment group (adjusted risk ratio, 0.96; 95% CI, 0.86 to 1.07). Necrotizing enterocolitis occurred in 70 of 1394 infants (5.0%) in the faster-increment group and 78 of 1399 (5.6%) in the slower-increment group (adjusted risk ratio, 0.88; 95% CI, 0.68 to 1.16).ConclusionsThere was no significant difference in survival without moderate or severe neurodevelopmental disability at 24 months in very preterm or very-low-birth-weight infants with a strategy of advancing milk feeding volumes in daily increments of 30 ml per kilogram as compared with 18 ml per kilogram. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; SIFT Current Controlled Trials number, ISRCTN76463425.).Copyright © 2019 Massachusetts Medical Society.
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