Clinical Trial: Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Coordinación de Investigación en Salud, Mexico

Current Primary Outcome: Presence of retinopathy of prematurity (ROP) [ Time Frame: ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age. ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Severity of ROP [ 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 ]

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


Original Secondary Outcome: Same as current

Information By: Coordinación de Investigación en Salud, Mexico

Dates:
Date Received: February 5, 2016
Date Started: February 2016
Date Completion: June 2019
Last Updated: January 12, 2017
Last Verified: January 2017