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Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

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ClinicalTrials.gov Identifier: NCT02683317
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Mariela Bernabe García, 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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Dietary Supplement: docosahexaenoic acid Dietary Supplement: sunflower oil Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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.
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 : February 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683317


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

Publications:
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Responsible Party: Mariela Bernabe García, Full Time Researcher, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02683317     History of Changes
Other Study ID Numbers: R-2015-785-051
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico:
DHA
Retinopathy of Prematurity

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Eye Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Infant, Premature, Diseases
Infant, Newborn, Diseases