Efficacy of Docosahexaenoic Acid for the Prevention of Necrotizing Enterocolitis in Preterm Infants: A Randomized Clinical Trial.

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.

• Authors: Mariela Bernabe-García, Philip C Calder, Raúl Villegas-Silva, Maricela Rodríguez-Cruz, Luis Chávez-Sánchez, Leonardo Cruz-Reynoso, Leovigildo Mateos-Sánchez, Gabriel Lara-Flores, Augusto R Aguilera-Joaquín, Luisa Sánchez-García
• Journal: Nutrients (Nutrients) Vol. 13 Issue 2 (Feb 17 2021) ISSN: 2072-6643 [Electronic] Switzerland
• PMID: 33671220 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Docosahexaenoic Acids

Topics

• Docosahexaenoic Acids (pharmacology)
• Double-Blind Method
• Enteral Nutrition
• Enterocolitis, Necrotizing (prevention & control)
• Erythrocytes (chemistry)
• Female
• Humans
• Infant, Newborn
• Infant, Premature
• Male
• Milk, Human (chemistry)