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Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Primary Purpose

Retinopathy of Prematurity

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
docosahexaenoic acid
sunflower oil
Sponsored by
Coordinación de Investigación en Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Retinopathy of Prematurity focused on measuring DHA, Retinopathy of Prematurity

Eligibility Criteria

60 Minutes - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

DHA group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of retinopathy of prematurity (ROP)
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

Severity of ROP
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

Full Information

First Posted
February 5, 2016
Last Updated
July 15, 2020
Sponsor
Coordinación de Investigación en Salud, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT02683317
Brief Title
Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity
Official Title
Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2016 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
DHA, Retinopathy of Prematurity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
docosahexaenoic acid
Other Intervention Name(s)
n-3 long chain polyunsaturated fatty acid
Intervention Description
Docosahexaenoic acid is a dietary supplement derived from algae.
Intervention Type
Dietary Supplement
Intervention Name(s)
sunflower oil
Intervention Description
Sunflower similar to the excipient used in experimental group
Primary Outcome Measure Information:
Title
Presence of retinopathy of prematurity (ROP)
Description
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.
Time Frame
ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.
Secondary Outcome Measure Information:
Title
Severity of ROP
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Minutes
Maximum Age & Unit of Time
2 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariela Bernabe-Garcia, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16750345
Citation
Lopez-Alarcon M, Bernabe-Garcia M, Del Prado M, Rivera D, Ruiz G, Maldonado J, Villegas R. Docosahexaenoic acid administered in the acute phase protects the nutritional status of septic neonates. Nutrition. 2006 Jul-Aug;22(7-8):731-7. doi: 10.1016/j.nut.2006.04.002. Epub 2006 Jun 5.
Results Reference
background
PubMed Identifier
22079797
Citation
Lopez-Alarcon M, Bernabe-Garcia M, del Valle O, Gonzalez-Moreno G, Martinez-Basilea A, Villegas R. Oral administration of docosahexaenoic acid attenuates interleukin-1beta response and clinical course of septic neonates. Nutrition. 2012 Apr;28(4):384-90. doi: 10.1016/j.nut.2011.07.016. Epub 2011 Nov 12.
Results Reference
background
PubMed Identifier
27394149
Citation
Bernabe-Garcia M, Lopez-Alarcon M, Villegas-Silva R, Mancilla-Ramirez J, Rodriguez-Cruz M, Maldonado-Hernandez J, Chavez-Rueda KA, Blanco-Favela F, Espinoza-Garcia L, Lagunes-Salazar S. Beneficial Effects of Enteral Docosahexaenoic Acid on the Markers of Inflammation and Clinical Outcomes of Neonates Undergoing Cardiovascular Surgery: An Intervention Study. Ann Nutr Metab. 2016;69(1):15-23. doi: 10.1159/000447498. Epub 2016 Jul 9.
Results Reference
background
PubMed Identifier
27806350
Citation
Bernabe-Garcia M, Lopez-Alarcon M, Salgado-Sosa A, Villegas-Silva R, Maldonado-Hernandez J, Rodriguez-Cruz M, Rivas-Ruiz R, Chavez-Sanchez L, Blanco-Favela FA, Mancilla-Ramirez J, Gordillo-Alvarez V, Madrigal-Muniz O. Enteral Docosahexaenoic Acid Reduces Analgesic Administration in Neonates Undergoing Cardiovascular Surgery. Ann Nutr Metab. 2016;69(2):150-160. doi: 10.1159/000452227. Epub 2016 Nov 2.
Results Reference
background
PubMed Identifier
30614004
Citation
Bernabe-Garcia M, Villegas-Silva R, Villavicencio-Torres A, Calder PC, Rodriguez-Cruz M, Maldonado-Hernandez J, Macias-Loaiza D, Lopez-Alarcon M, Inda-Icaza P, Cruz-Reynoso L. Enteral Docosahexaenoic Acid and Retinopathy of Prematurity: A Randomized Clinical Trial. JPEN J Parenter Enteral Nutr. 2019 Sep;43(7):874-882. doi: 10.1002/jpen.1497. Epub 2019 Jan 6.
Results Reference
result

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Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

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