Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Not Applicable

Completed

• Conditions: Retinopathy of Prematurity
• Interventions: Dietary Supplement: sunflower oil; Dietary Supplement: docosahexaenoic acid

• Registration Number: NCT02683317
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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 Description

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 Timeline

• Study First Submitted: 2016-02-05
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-17
• Study Start: 2016-02-22
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	sunflower oil	Control group will receive sunflower oil, the excipient of the DHA in our intervention. They will receive it once a day, administered by enteral feeding throughout 14 days.
DHA group	docosahexaenoic acid	Experimental group will receive 75 mg of docosahexaenoic acid per kilo of baseline weight in one dose per day, administered by enteral feeding throughout 14 days.

Primary Outcome Measures

Name	Time	Method
Presence of retinopathy of prematurity (ROP)	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.

Secondary Outcome Measures

Name	Time	Method
Severity of ROP	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

Trial Locations

Locations (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social; 🇲🇽 Mexico, Distrito Federal, Mexico