A Phase 4 interventional study of Vitamin E, Vitamin C in Birth Asphyxia, sponsored by Sir Takhtasinhji General Hospital. Completed at 1 site in India. Open to participants aged 1 Minute to 6 Hours. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Sir Takhtasinhji General Hospital · Phase 4, Interventional, and Prevention
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.
106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.
This study's enrollment of 95 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.
Browse Asphyxia Neonatorum studies →Sir Takhtasinhji General Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Single dose of vitamin E drops 200 IU within 6 hours of birth and vitamin C tablet 250 mg in pulverised form (2 doses at 24 hr interval) via infant feeding tube
Drug: Vitamin E, Vitamin C
Drug pages: Vitamin E · Ascorbic Acid
Also known as: Evion® drops, Tablet Limcee®
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.
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.
progression of birth asphyxia in terms of HIE Sarnat grading.
Time frame: at 12 hours
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.
Grading of HIE and discharge or death and sequel at followup.
Time frame: 15 days
Ran from May 2013 to primary completion in Sep 2013, 4 months.
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vitamin E · Ascorbic Acid
Sir Takhtasinhji General Hospital