Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial

JPEN J Parenter Enteral Nutr. 2019 Sep;43(7):874-882. doi: 10.1002/jpen.1497. Epub 2019 Jan 6.

Abstract

Background: Retinopathy of prematurity (ROP) is a disorder of the retina of low-birth-weight preterm infants that potentially leads to blindness. Docosahexaenoic acid (DHA), is protective in experimental models, but its administration as part of parenteral nutrition has shown inconsistent results. We test the effect of enteral DHA to prevent ROP and/or severity and to reduce hospital stay.

Methods: This was a double-blind parallel clinical trial. Preterm infants (n = 110; 55 per group) with birth weight <1500 g but ≥1000 g were recruited in a neonatal intensive care unit. Infants were randomized to receive 75 mg of DHA/kg/d (DHA group) or high oleic sunflower oil (control group) for 14 days by enteral feeding. The effect of DHA was evaluated on any stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay. Groups were compared with relative risk (RR) and 95% confidence interval (CI), Fisher's exact test, Student's t-test, or Mann-Whitney U-test, as appropriate. Logistic regression was applied to adjust for confounders.

Results: There was no difference between the DHA and control groups in ROP risk (RR for DHA = 0.79; 95% CI, 0.49-1.27; P = 0.33). However, patients who received DHA showed lower risk for stage 3 ROP (RR for DHA = 0.66; 95% CI, 0.44-0.99; P = 0.03). After adjusting for confounders, this decreased risk remained significant (adjusted odds ratio = 0.10; 95% CI, 0.011-0.886; P = 0.04). Hospital stay was similar between groups.

Conclusion: Enteral DHA may reduce the incidence of stage 3 ROP.

Trial registration: ClinicalTrials.gov NCT02683317.

Keywords: DHA; ROP; neonate; omega-3 fatty acids; premature infant; preterm; retinopathy.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Docosahexaenoic Acids / therapeutic use*
  • Double-Blind Method
  • Enteral Nutrition*
  • Female
  • Humans
  • Infant, Low Birth Weight
  • Infant, Newborn
  • Infant, Premature*
  • Infant, Premature, Diseases / prevention & control*
  • Infant, Premature, Diseases / therapy
  • Logistic Models
  • Male
  • Parenteral Nutrition
  • Retinopathy of Prematurity / prevention & control*
  • Retinopathy of Prematurity / therapy

Substances

  • Docosahexaenoic Acids

Associated data

  • ClinicalTrials.gov/NCT02683317