Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity
Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2016
CompletedStudy Start
First participant enrolled
February 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedJuly 17, 2020
July 1, 2020
1.7 years
February 5, 2016
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
ROP will be evaluated from 4 to 5 weeks after birth throughout 42-45 of corrected gestational age.
Secondary Outcomes (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
Study Arms (2)
DHA group
EXPERIMENTALExperimental 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
SHAM COMPARATORControl 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.
Interventions
Docosahexaenoic acid is a dietary supplement derived from algae.
Sunflower similar to the excipient used in experimental group
Eligibility Criteria
You may qualify if:
- Birth weight \< 1500 g
- Plan to feed by enteral way at a short term
- Written informed consent, signed by both parents.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06720, Mexico
Related Publications (5)
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.
PMID: 16750345BACKGROUNDLopez-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.
PMID: 22079797BACKGROUNDBernabe-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.
PMID: 27394149BACKGROUNDBernabe-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.
PMID: 27806350BACKGROUNDBernabe-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.
PMID: 30614004RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariela Bernabe-Garcia, PhD
Instituto Mexicano del Seguro Social
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Time Researcher
Study Record Dates
First Submitted
February 5, 2016
First Posted
February 17, 2016
Study Start
February 22, 2016
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
July 17, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share