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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
95
NICU, Sir T Hospital, Bhavnagar
Bhavnagar, Gujarat, India
To assess the role of first day high-dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequel in newborns with birth asphyxia.
Vitamin C and E were initiated orally within 6 hours of birth.
Time frame: 6 months
Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.
Deaths and Sequel were measured.
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.
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