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Efficacy of docosahexaenoic acid for the prevention of necrotizing enterocolitis in preterm infants: A randomized clinical trial

Efficacy of docosahexaenoic acid for the prevention of necrotizing enterocolitis in preterm infants: A randomized clinical trial
Efficacy of docosahexaenoic acid for the prevention of necrotizing enterocolitis in preterm infants: A randomized clinical trial

Necrotizing enterocolitis (NEC) is an inflammatory bowel disease and a leading cause of morbidity and mortality in preterm infants. In this study, a randomized double-blind parallel-group (1:1) trial was carried out in two neonatal intensive care units of two tertiary hospitals. Two hundred and twenty-five preterm newborns with an expected functional gastrointestinal tract were recruited and received an enteral dose of 75 mg of docosahexaenoic acid (DHA)/kg body weight or high-oleic sunflower oil daily for 14 days from the first enteral feed after birth. Confirmed NEC was evaluated with Bell’s scale from stage ≥ IIa. Two hundred and fourteen randomized infants were analyzed in terms of the intent-to-treat (DHA-group: n = 105; control-group: n = 109); data for two hundred infants were analysed per protocol. Confirmed NEC was lower in infants from the DHA-group compared with the control-group (0/100 vs. 7/100; p = 0.007), with RR = 0.93 (95% CI 0.881 to 0.981), risk difference = −7%, (95% CI −12.00 to −1.99), and number needed-to-treat = 15 (95% CI 8.3 to 50). Intent-to-treat analysis showed a lower level of treatment failure in the DHA-group compared with the control-group (6/105 (6%) vs. 16/109 (15%); p = 0.03, RR = 0.905, (95% CI 0.826 to 0.991)). The results after multivariate-regression analysis remained significant. Adverse events (apart from the incidence of NEC) were not different between groups. A daily dose of DHA for 14 days starting with the first enteral feed may prevent NEC in preterm infants.
DHA, Hospital stay, Infant, Inflammation, N-3 fatty acids, Necrotizing enterocolitis, Neonatal intensive care unit, Omega-3, Prematurity, Very low birth weight
2072-6643
1-15
Bernabe-García, Mariela
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Calder, Philip
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Villegas-Silva, Raúl
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Rodríguez-Cruz, Maricela
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Chávez- Sánchez, Luis
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Cruz-Reynoso, Leonardo
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Mateos-Sánchez, Leovigildo
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Lara-Flores, Gabriel
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Aguilera-Joaquín, Augusto R.
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Sánchez-García, Luisa
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Bernabe-García, Mariela
88db8d44-8e2c-4498-81e7-7252022d65ca
Calder, Philip
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Villegas-Silva, Raúl
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Rodríguez-Cruz, Maricela
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Chávez- Sánchez, Luis
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Cruz-Reynoso, Leonardo
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Mateos-Sánchez, Leovigildo
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Lara-Flores, Gabriel
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Aguilera-Joaquín, Augusto R.
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Sánchez-García, Luisa
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Bernabe-García, Mariela, Calder, Philip, Villegas-Silva, Raúl, Rodríguez-Cruz, Maricela, Chávez- Sánchez, Luis, Cruz-Reynoso, Leonardo, Mateos-Sánchez, Leovigildo, Lara-Flores, Gabriel, Aguilera-Joaquín, Augusto R. and Sánchez-García, Luisa (2021) Efficacy of docosahexaenoic acid for the prevention of necrotizing enterocolitis in preterm infants: A randomized clinical trial. Nutrients, 13 (2), 1-15, [648]. (doi:10.3390/nu13020648).

Record type: Article

Abstract


Necrotizing enterocolitis (NEC) is an inflammatory bowel disease and a leading cause of morbidity and mortality in preterm infants. In this study, a randomized double-blind parallel-group (1:1) trial was carried out in two neonatal intensive care units of two tertiary hospitals. Two hundred and twenty-five preterm newborns with an expected functional gastrointestinal tract were recruited and received an enteral dose of 75 mg of docosahexaenoic acid (DHA)/kg body weight or high-oleic sunflower oil daily for 14 days from the first enteral feed after birth. Confirmed NEC was evaluated with Bell’s scale from stage ≥ IIa. Two hundred and fourteen randomized infants were analyzed in terms of the intent-to-treat (DHA-group: n = 105; control-group: n = 109); data for two hundred infants were analysed per protocol. Confirmed NEC was lower in infants from the DHA-group compared with the control-group (0/100 vs. 7/100; p = 0.007), with RR = 0.93 (95% CI 0.881 to 0.981), risk difference = −7%, (95% CI −12.00 to −1.99), and number needed-to-treat = 15 (95% CI 8.3 to 50). Intent-to-treat analysis showed a lower level of treatment failure in the DHA-group compared with the control-group (6/105 (6%) vs. 16/109 (15%); p = 0.03, RR = 0.905, (95% CI 0.826 to 0.991)). The results after multivariate-regression analysis remained significant. Adverse events (apart from the incidence of NEC) were not different between groups. A daily dose of DHA for 14 days starting with the first enteral feed may prevent NEC in preterm infants.

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Accepted/In Press date: 12 February 2021
e-pub ahead of print date: 17 February 2021
Published date: 17 February 2021
Additional Information: Funding Information: This research was funded by Consejo Nacional de Ciencia y Tecnolog?a (CONACYT), M?xico, grant number Salud-2011-01-161643, in support of the research work (to M.B.-G.). Funding Information: Funding: This research was funded by Consejo Nacional de Ciencia y Tecnología (CONACYT), México, grant number Salud-2011-01-161643, in support of the research work (to M.B.-G.). Publisher Copyright: © 2021 by the authors. Licensee MDPI, Basel, Switzerland. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
Keywords: DHA, Hospital stay, Infant, Inflammation, N-3 fatty acids, Necrotizing enterocolitis, Neonatal intensive care unit, Omega-3, Prematurity, Very low birth weight

Identifiers

Local EPrints ID: 447053
URI: http://eprints.soton.ac.uk/id/eprint/447053
ISSN: 2072-6643
PURE UUID: 807bb92a-579b-4231-ba82-5a4e639dcc37
ORCID for Philip Calder: ORCID iD orcid.org/0000-0002-6038-710X

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Date deposited: 02 Mar 2021 17:31
Last modified: 26 Nov 2021 02:38

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Contributors

Author: Mariela Bernabe-García
Author: Philip Calder ORCID iD
Author: Raúl Villegas-Silva
Author: Maricela Rodríguez-Cruz
Author: Luis Chávez- Sánchez
Author: Leonardo Cruz-Reynoso
Author: Leovigildo Mateos-Sánchez
Author: Gabriel Lara-Flores
Author: Augusto R. Aguilera-Joaquín
Author: Luisa Sánchez-García

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