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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Treatments: alpha-Tocopherol; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria:

• Newborn weight < 1500 g

• Diagnosed respiratory distress syndrome (RDS)

• Patients who required mechanical ventilation or CPAP

Exclusion Criteria:

• Congenital malformations

• Rh incompatibility

• Non-immune or immune hydrops fetalis

• Intraventricular haemorrhage III/IV grade