Retinopathy of Prematurity
Conditions
Keywords
DHA, 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.
Interventions
DIETARY_SUPPLEMENTdocosahexaenoic acid
Docosahexaenoic acid is a dietary supplement derived from algae.
DIETARY_SUPPLEMENTsunflower oil
Sunflower similar to the excipient used in experimental group
Sponsors
Coordinación de Investigación en Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Regarding the Study phase, the intervention was a nutraceutical, docosahexaenoic acid, derived from omega 3 fatty acid family.
Eligibility
Sex/Gender
ALL
Age
60 Minutes to 2 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of retinopathy of prematurity (ROP) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Mexico
Outcome results
None listed