Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-22

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Retinopathy of Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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DHA group

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.

Group Type EXPERIMENTAL

docosahexaenoic acid

Intervention Type DIETARY_SUPPLEMENT

Docosahexaenoic acid is a dietary supplement derived from algae.

Control group

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.

Group Type SHAM_COMPARATOR

sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Sunflower similar to the excipient used in experimental group

Interventions

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docosahexaenoic acid

Docosahexaenoic acid is a dietary supplement derived from algae.

Intervention Type DIETARY_SUPPLEMENT

sunflower oil

Sunflower similar to the excipient used in experimental group

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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n-3 long chain polyunsaturated fatty acid

Eligibility Criteria

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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

Minimum Eligible Age

60 Minutes

Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No