NCT01743742

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Sir Takhtasinhji General Hospital · Other Government
• Sex: All
• Age: 1 Minute – 6 Hours
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Birth Asphyxia

Interventions

Type	Name	Description
DRUG	Vitamin E, Vitamin C

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2012-12-06
• Last updated: 2022-07-07

Locations

1 site across 1 country: India