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Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

NCT03274596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2017-09-07

No results posted yet for this study

Summary

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Conditions

  • Retinopathy of Prematurity

Interventions

DRUG

Vitamin E

DRUG

Placebo

Sponsors & Collaborators

  • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

    lead OTHER_GOV

Principal Investigators

  • Silvia Romero-Maldonado, M.Sc. · Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-01
Primary Completion
2015-10-01
Completion
2015-12-01

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274596 on ClinicalTrials.gov