Clinical Trial: Single High Dose Vitamin C, E in Severe Birth Asphyxia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Single High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia)in Newborns

Brief Summary: To study the role of single high dose vitamin E and vitamin C in hypoxic ischemic encephalopathy in newborns, in reduction of morbidity and adverse neurodevelopmental sequelae.

Detailed Summary:
Sponsor: Sir Takhtasinhji General Hospital

Current Primary Outcome: To assess the role of single high dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequelae in newborns with birth asphyxia. [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 15 DAYS. ]

Original Secondary Outcome: Same as current

Information By: Sir Takhtasinhji General Hospital

Dates:
Date Received: November 29, 2012
Date Started: May 2013
Date Completion:
Last Updated: August 22, 2014
Last Verified: August 2014