Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

July 15, 2020 updated by: Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico

Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 06720
        • Unit of research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: docosahexaenoic acid
Docosahexaenoic acid is a dietary supplement derived from algae.
Other Names:
  • n-3 long chain polyunsaturated fatty acid
Sham Comparator: 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.
Dietary supplement: sunflower oil
Sunflower similar to the excipient used in experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

February 5, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2015-785-051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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