38Background and Aim: Retinopathy of prematurity (ROP) is a disorder of the retina of low-39 birth-weight preterm infants that potentially leads to blindness. Docosahexaenoic acid 40 (DHA), a component of fish oil, is protective in experimental models. Administration of 41 fish oil as part of parenteral nutrition has shown inconsistent results. We aimed to test the 42 effect of enteral DHA to prevent ROP development and/or severity, and to reduce hospital 43 stay. 44 Methods: This was a double-blind, parallel clinical-trial. Preterm infants (n = 110; 55 per 45 group) with birth weight <1500g but >1000g were recruited in a level 3 NICU. Infants were 46 randomized to receive 75 mg of DHA/kg/day (DHA-group) or high oleic sunflower oil 47 (control-group) for 14 days by enteral feeding. The effect of DHA was evaluated on any 48 stage of ROP, severe ROP (stage ≥3) incidence, and hospital stay. Groups were compared 49 with relative risk and 95% CI, Fisher's Exact, Student's t or Mann-Whitney U tests, as 50 appropriate. Logistic regression was applied to adjust for confounders.51Results: There was no difference between the DHA and control groups in ROP risk (RR for 52 DHA= 0.79; 95% CI, 0.49-1.27, P= 0.33). However, patients who received DHA showed 53 lower risk for stage 3 ROP than controls (RR for DHA= 0.66; 95% CI, 0.44-0.99, P= 0.03).
54After adjusting for confounders, enteral DHA decreased the risk of stage 3 ROP (OR adj. = 55 0.10; 95% CI, 0.011-0.886; P= 0.04). Hospital stay was not different between groups.
56Conclusion: Enteral DHA may reduce the incidence of stage 3 ROP. 57 58