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
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Dietary Supplement: docosahexaenoic acid Dietary Supplement: sunflower oil||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|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)|
|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|
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
- 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.
- 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:
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
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
|Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social|
|Mexico, Distrito Federal, Mexico, 06720|
|Principal Investigator:||Mariela Bernabe-Garcia, PhD||Instituto Mexicano del Seguro Social|