Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Coordinación de Investigación en Salud, Mexico

Status: Completed

Conditions: Retinopathy of Prematurity

Treatments: Dietary Supplement: sunflower oil; Dietary Supplement: docosahexaenoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02683317

R-2015-785-051

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 60 minutes to 2 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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110 participants in 2 patient groups

DHA group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: docosahexaenoic acid

Control group

Sham Comparator group

Description:

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.

Treatment:

Dietary Supplement: sunflower oil