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Controlled trial of two incremental milk-feeding rates in preterm infants

Controlled trial of two incremental milk-feeding rates in preterm infants
Controlled trial of two incremental milk-feeding rates in preterm infants

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.

0028-4793
1434-1443
Dorling, Jon
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Abbott, Jane
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Berrington, Janet
7abdd601-9ade-4b12-a5ef-22fac14ae86f
Bosiak, Beth
e42a64db-aa13-4ab3-8673-5b1bc2b81571
Bowler, Ursula
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Boyle, Elaine
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Embleton, Nicholas
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Hewer, Oliver
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Johnson, Samantha
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Juszczak, Edmund
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Leaf, Alison
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Linsell, Louise
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McCormick, Kenny
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McGuire, William
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Omar, Omar
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Partlett, Christopher
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Patel, Mehali
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Roberts, Tracy
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Stenson, Ben
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Townend, John
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SIFT Investigators Group
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Abbott, Jane
e07b7f80-d967-49d1-9879-c30b2b767782
Berrington, Janet
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Bosiak, Beth
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Bowler, Ursula
49570c44-66b8-4121-a220-3de7e6cf1a0d
Boyle, Elaine
0a18aac0-3ba2-4463-a07c-f5957ed4ceb7
Embleton, Nicholas
5c621f1e-cee5-4efa-ac43-8a195410c11c
Hewer, Oliver
dc19957a-f2ce-449e-b2bf-699ddc42528e
Johnson, Samantha
eee3bac4-3cc8-40f9-8038-4a0177249d6f
Juszczak, Edmund
9267758e-8ab8-44c7-ab14-48ef82fa6b6e
Leaf, Alison
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Linsell, Louise
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McCormick, Kenny
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McGuire, William
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Omar, Omar
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Partlett, Christopher
ff1ea90b-5254-4a96-809a-14d05b13a0d7
Patel, Mehali
c589a05c-d5b3-409e-80c1-70c1b236fdeb
Roberts, Tracy
6964df84-5fec-42a5-aa2f-fb207b6fb2dc
Stenson, Ben
21656459-9347-4ac8-8429-cb11c27dad37
Townend, John
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Dorling, Jon, Abbott, Jane and Berrington, Janet , SIFT Investigators Group (2019) Controlled trial of two incremental milk-feeding rates in preterm infants. New England Journal of Medicine, 381 (15), 1434-1443. (doi:10.1056/NEJMoa1816654).

Record type: Article

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.

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e-pub ahead of print date: 10 October 2019
Additional Information: Funding Information: Supported by the Health Technology Assessment Programme of the National Institute for Health Research.

Identifiers

Local EPrints ID: 484992
URI: http://eprints.soton.ac.uk/id/eprint/484992
ISSN: 0028-4793
PURE UUID: 428a010e-d6d5-4f83-9183-de5212635891
ORCID for Jon Dorling: ORCID iD orcid.org/0000-0002-1691-3221

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Date deposited: 27 Nov 2023 18:01
Last modified: 06 Jun 2024 02:19

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Contributors

Author: Jon Dorling ORCID iD
Author: Jane Abbott
Author: Janet Berrington
Author: Beth Bosiak
Author: Ursula Bowler
Author: Elaine Boyle
Author: Nicholas Embleton
Author: Oliver Hewer
Author: Samantha Johnson
Author: Edmund Juszczak
Author: Alison Leaf
Author: Louise Linsell
Author: Kenny McCormick
Author: William McGuire
Author: Omar Omar
Author: Christopher Partlett
Author: Mehali Patel
Author: Tracy Roberts
Author: Ben Stenson
Author: John Townend
Corporate Author: SIFT Investigators Group

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