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First-day High Dose Vitamin C, E in Severe Birth Asphyxia — CEBA  

Birth Asphyxia Clinical Trial

Official title:
The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns

Clinical Trial Summary

To study the role of first-day high dose oral vitamin C and first-day single high dose oral vitamin E in hypoxic-ischemic encephalopathy in newborns, in the reduction of morbidity and adverse neurodevelopmental sequelae.

Clinical Trial Description

Design: A prospective, randomized controlled trial over 5 months. Patients: Newborns admitted within 6 hours after birth with gestation >32 weeks, Apgar score of <6 at 5 minutes, features suggestive of neonatal encephalopathy. Intervention: After randomization, Group A newborns received oral vitamin C 250 mg once a day within a 24-hour interval along with a single dose of vitamin E 200 IU. Group B newborns received no intervention. Outcome measures: Severity and progression of birth asphyxia, duration of hospitalization and mechanical ventilation, mortality, and neurodevelopmental outcome. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01743742
Study type Interventional
Source Sir Takhtasinhji General Hospital
Contact
Status Completed
Phase Phase 4
Start date May 2013
Completion date October 2013
View Details
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