Enteral Administration of Docosahexaenoic Acid to Prevent Retinopathy of Prematurity

C

Coordinación de Investigación en Salud, Mexico

Status

Completed

Conditions

Retinopathy of Prematurity

Treatments

Dietary Supplement: sunflower oil
Dietary Supplement: docosahexaenoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02683317
R-2015-785-051

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

60 minutes to 2 weeks old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

110 participants in 2 patient groups

DHA group
Experimental group
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.
Treatment:
Dietary Supplement: docosahexaenoic acid
Control group
Sham Comparator group
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.
Treatment:
Dietary Supplement: sunflower oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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