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Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Sponsor
Coordinación de Investigación en Salud, Mexico (Other)
Overall Status
Completed
CT.gov ID
NCT02683317
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
20.3
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: docosahexaenoic acid
  • Dietary Supplement: sunflower oil
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
Actual Study Start Date :
Feb 22, 2016
Actual Primary Completion Date :
Oct 31, 2017
Actual Study Completion Date :
Oct 31, 2017

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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: 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. 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 ROP in zone II or III, Stage 1 or 2 without Plus, require periodic monitoring. ROP in remission Without retinopathy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Minutes to 2 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social Mexico Distrito Federal Mexico 06720

    Sponsors and Collaborators

    • Coordinación de Investigación en Salud, Mexico

    Investigators

    • Principal Investigator: Mariela Bernabe-Garcia, PhD, Instituto Mexicano del Seguro Social

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mariela Bernabe García, Full Time Researcher, Coordinación de Investigación en Salud, Mexico
    ClinicalTrials.gov Identifier:
    NCT02683317
    Other Study ID Numbers:
    • R-2015-785-051
    First Posted:
    Feb 17, 2016
    Last Update Posted:
    Jul 17, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Mariela Bernabe García, Full Time Researcher, Coordinación de Investigación en Salud, Mexico
    DHA
    Retinopathy of Prematurity
    Additional relevant MeSH terms:
    Retinal Diseases
    Retinopathy of Prematurity
    Premature Birth

    Study Results

    No Results Posted as of Jul 17, 2020