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N Engl J Med. 2019 Oct 10;381(15):1434-1443. doi: 10.1056/NEJMoa1816654.

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

Collaborators (359)

Babirecki M, Bala P, Kitching A, Swanepoel M, Tillotsen G, Andrews M, Bunn J, Horsley V, Armstrong D, Brown J, Babarao S, Hughes A, Hughes S, Lewis L, Rice R, McQuarrie H, Wickham T, Wigfield R, Plunkett A, Alamad L, El Beltagy RE, Chambers F, Charles L, Potter S, Sivakumar S, Bisso F, Hopkins J, Ingram L, Storey I, Barrow H, Russell AB, Holder G, Jackson RE, Simcox E, Douglas J, Ingram L, Seal S, Wane R, Young K, Collier HL, Burgess S, Crosbie E, Smith A, Somerville K, Gale C, Modi N, Foo A, Hardy L, Brearey S, Burchett C, de-Beger S, Farmer Y, Gilpin S, Quinn P, Ratcliffe J, Smith M, Guthrie S, Chang J, Cook A, Wardley V, Webb L, Cooper C, Jayachandran D, McIntyre J, Ratnayaka M, Smith CJ, Unsworth V, Aworinde O, Maxwell N, Meredith L, Sharman SJ, Tyson S, Adiotomre P, Maver D, Ahmad SJ, Allatt K, Besley S, Smith H, Guy S, Armstrong H, Mitra A, Khader KA, Wilson D, Blair A, MacFadyen U, Thompson K, Banfield G, Mallik A, Marriott T, Moghal N, Mupanemunda R, Beames S, Wagstaff MH, Jones A, Peters MJ, Elliott-Jones R, Gowda G, Rahman S, Wills L, Meyrick S, Aladangady N, Mathew A, Achia A, Bartley G, Bolton D, Gaili H, Trufhitt S, Bell S, Forster M, Lal M, Smith H, Malpas TJ, Bayliss P, Cook J, Coombs R, Pye C, Barlow S, Davis S, McCormick K, Bilolikar H, Marinova J, White S, Hickey A, Lisseman-Stones Y, Moulds C, Noble V, Rhodes S, Whysall K, Allen M, Burton D, Heath S, Johnson K, Laing S, Reilly C, Spencer C, Uryn L, Astles R, Boyle E, Hubbard M, Bramhall S, Smith SA, Tapscott S, Thirumurugan A, Kefas J, Harvey K, Howell B, McGowan P, Turner M, Windrow J, Birch J, Keenan N, Henley J, Harizaj H, Soe A, Moka S, Antoine T, Charlton S, Forster M, Mann RJ, O'Brien K, Coronella B, Twomey A, Denyer R, Kempson S, Kumararatne B, Skinner A, Parker H, Shackleton J, Clarke P, Mills E, Jones V, Graham H, Gupta S, Thompson F, Brooks G, Batey N, Batra D, Craig S, Dorling J, Kwok TC, Lynch J, Paton A, Sibert J, Smitheram R, Haslam Z, McBride T, Morrison M, Goodyear P, Johnson C, Pearson A, Crawford M, Castle G, Deakin K, Gibson D, McEwan P, Hoare C, Crowley P, Johnson MJ, Leaf A, Oates C, Pond J, Rhodes-Kitson J, Weddell J, Dunning G, Radford H, Crawford I, Mactier H, Pople M, Scorrer T, Bosman D, Dale A, Frary A, Rubin S, Sanka S, Ahmed M, Backhouse C, Boswell S, Lopez W, Mannan K, Forsyth A, Van Der Heide P, Bashir I, Lomas B, Macfarlane P, Fernandez R, Sobowiec Kouman S, Hallett S, Pritchard N, Zelisko M, Bromage B, Craig G, Kumar Y, Osborn H, Bartle D, Halpin J, Jones N, Massey J, Roberts A, Tipper J, Ward S, Fitzmaurice M, Foote K, Skinner S, Clark L, Stenson B, Castro J, Craig S, McCreesh P, Millar M, O'Neill M, Walker A, Deshpande S, Kirk S, Owen C, Abbott L, Harrison A, Hollins J, Jones R, Lewney K, Pringle R, Riches V, Roe E, Barratt A, Downie C, Jones S, Berrington J, Downes T, Embleton N, Groombridge J, Kimber A, Pirnie J, Shah L, Skeath T, Smith L, Zalewski S, Mahadevan-Bava S, Merotra S, Twiss AJ, Brown N, Diment S, Gaythorpe A, Kapoor S, Banerjee S, Cook A, Goldring H, Ketty M, Elena N, McNamee L, Thorpe L, McKay L, Peters C, Gay A, Mannix P, Stubbs D, Hayward N, Kennea N, Garr R, Kamarova H, Hartung R, Yasin S, Waddell S, Burtwell C, Butterworth S, Cairns P, Davis J, Innoles J, Holland N, Reynolds P, Wells K, Beech S, Floyd S, Sarkar G, Tyler G, Abu-Harb M, Coppard D, Marshall K, Turnbull E, Bearne H, Garfield-Smith J, Palmer J, Paul S, Raman M, Butler S, Gupta R, Kollipara N, Roper A, Thomas D, Blake K, de Boer RC, Ward G, Jagodzinski J, Kuna J, Garbash M, Cheadle W, Janakiraman S, Ramshaw A, Ainsworth SB, Gour R, Hulikere S, Rogers N, Webb D, Jones W, Ben-Hamida M, Gad K, Moore C, Sinnathuray KR, George S, Harrison J, O'Brien S, Vasu V, Ibhanesebhor S, Vigni D, Gallagher A, Kelly D, Townsend C, Hobden G, Vamvakiti E, McGuire W, Millman G.

Author information

1
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.

Abstract

BACKGROUND:

Observational 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.

METHODS:

We 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.

RESULTS:

Among 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).

CONCLUSIONS:

There 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.).

PMID:
31597020
DOI:
10.1056/NEJMoa1816654
[Indexed for MEDLINE]

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