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

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sir Takhtasinhji General Hospital
• Treatments: alpha-Tocopherol; Ascorbic Acid; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

Inclusion Criteria

1. Apgar score of <6 at 5 minutes

2. Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)

Exclusion Criteria

1. Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth

2. Gestational age <32 weeks.

3. Lethal congenital anomaly