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