Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Coordinación de Investigación en Salud, Mexico110 enrolled

Overview

The purpose of this study is to evaluate whether docosahexaenoic acid given by enteral feeding prevent retinopathy of prematurity and/or diminish its severity in preterm infants.

Preterm neonates who start receiving enteral feeding will receive the intervention with docosahexaenoic acid (DHA) since the first day and throughout 14 days, one dose per day. The opthalmic evaluation will be done after 4-5 weeks after birth and followed until 42-45 corrected gestational age.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

110

Conditions

Retinopathy of Prematurity

Interventions

docosahexaenoic acidDIETARY_SUPPLEMENT

Docosahexaenoic acid is a dietary supplement derived from algae.

sunflower oilDIETARY_SUPPLEMENT

Sunflower similar to the excipient used in experimental group

Eligibility

Sex: ALLMin age: 60 MinutesMax age: 2 Weeks

Medical Language ↔ Plain English

Inclusion Criteria: * Birth weight \< 1500 g * Plan to feed by enteral way at a short term * Written informed consent, signed by both parents. Exclusion Criteria: * Congenital malformations that avoid enteral feeding * immunosuppressor diseases * Need for major surgery * Persistent bleeding at any level * Mother taking n-3 supplements and planning to breastfed * Parents who decline the authorization for participating in the study * Early discharge to other hospital outside the metropolitan area

Locations (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Mexico City, Mexico City, Mexico

Outcomes

Primary Outcomes

Presence of retinopathy of prematurity (ROP)

The medical screening to determine the presence ROP will include the exhaustive search of injury on the zone, stage and the presence of plus disease in retina of the preterm infants. The measure unit is frequency of ROP (presence =1 or absence=0) registering the corrected gestational age of the first identification.

Time frame: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.

Secondary Outcomes

Severity of ROP

The study will determine the severity of retinopathy of prematurity as ordinal variable with frequencies, according to the following classification: 1. ROP stage 1 or threshold needs treatment: * ROP in Zone I any stage if it is associate to presence of Plus. * ROP stage 1 in Zone I + Plus disease * ROP stage 2 in Zone I + Plus disease * ROP stage 3 in Zone I + Plus disease * ROP in Zone I Stage 3 with or without Plus disease. * ROP in Zone II Stage 2 or 3 + Plus disease. 2. ROP Stage 2 or pre-threshold, require close monitoring: * ROP in Zone I, Stage 1 or 2 without Plus * ROP in Zone II, Stage 3 without Plus 3. ROP in zone II or III, Stage 1 or 2 without Plus, require periodic monitoring. 4. ROP in remission 5. Without retinopathy

Time frame: ROP will be evaluated as changes in each retina's eye from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age

Data from ClinicalTrials.gov

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