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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1434-1443
Number of pages10
JournalNew England Journal of Medicine
Volume381
Issue number15
DOIs
Publication statusPublished - 10 Oct 2019

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Premature Infants
Necrotizing Enterocolitis
Milk
Sepsis
Very Low Birth Weight Infant
Odds Ratio
Confidence Intervals
Enteral Nutrition
Cerebral Palsy
Random Allocation
Body Weight

ASJC Scopus subject areas

  • Medicine(all)

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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

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.

In: New England Journal of Medicine, Vol. 381, No. 15, 10.10.2019, p. 1434-1443.

Research output: Contribution to journalArticle

Dorling, J, Abbott, J, Berrington, J, Bosiak, B, Bowler, U, Boyle, E, Embleton, N, Hewer, O, Johnson, S, Juszczak, E, Leaf, A, Linsell, L, McCormick, K, McGuire, W, Omar, O, Partlett, C, Patel, M, Roberts, T, Stenson, B & Townend, J 2019, 'Controlled trial of two incremental milk-feeding rates in preterm infants', New England Journal of Medicine, vol. 381, no. 15, pp. 1434-1443. https://doi.org/10.1056/NEJMoa1816654
Dorling J, Abbott J, Berrington J, Bosiak B, Bowler U, Boyle E et al. Controlled trial of two incremental milk-feeding rates in preterm infants. New England Journal of Medicine. 2019 Oct 10;381(15):1434-1443. https://doi.org/10.1056/NEJMoa1816654
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. / Controlled trial of two incremental milk-feeding rates in preterm infants. In: New England Journal of Medicine. 2019 ; Vol. 381, No. 15. pp. 1434-1443.
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AU - Dorling, Jon

AU - Abbott, Jane

AU - Berrington, Janet

AU - Bosiak, Beth

AU - Bowler, Ursula

AU - Boyle, Elaine

AU - Embleton, Nicholas

AU - Hewer, Oliver

AU - Johnson, Samantha

AU - Juszczak, Edmund

AU - Leaf, Alison

AU - Linsell, Louise

AU - McCormick, Kenny

AU - McGuire, William

AU - Omar, Omar

AU - Partlett, Christopher

AU - Patel, Mehali

AU - Roberts, Tracy

AU - Stenson, Ben

AU - Townend, John

PY - 2019/10/10

Y1 - 2019/10/10

N2 - 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.

AB - 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.

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