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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

Tracking Information
First Submitted Date  ICMJE February 5, 2016
First Posted Date  ICMJE February 17, 2016
Last Update Posted Date February 2, 2018
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02683317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity
Official Title  ICMJE Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Retinopathy of Prematurity
Intervention  ICMJE
  • Dietary Supplement: docosahexaenoic acid
    Docosahexaenoic acid is a dietary supplement derived from algae.
    Other Name: n-3 long chain polyunsaturated fatty acid
  • Dietary Supplement: sunflower oil
    Sunflower similar to the excipient used in experimental group
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: docosahexaenoic 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.

    Intervention: Dietary Supplement: sunflower oil
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2016)
100
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683317
Other Study ID Numbers  ICMJE R-2015-785-051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mariela Bernabe García, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariela Bernabe-Garcia, PhD Instituto Mexicano del Seguro Social
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP