Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Enteral Administration of Docosahexaenoic Acid on Development of the Retinopathy of Prematurity

Conditions
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Retinopathy of Prematurity

Intervention / Treatment
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* Dietary Supplement: docosahexaenoic acid
* Dietary Supplement: sunflower oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Minutes
Maximum Age: 2 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA group<br>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<br>* Docosahexaenoic acid is a dietary supplement derived from algae.<br>* Other names: n-3 long chain polyunsaturated fatty acid;|
| Sham Comparator: Control group<br>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<br>* Sunflower similar to the excipient used in experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHA, Retinopathy of Prematurity