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

Sir Takhtasinhji General Hospital

Status and phase: Completed; Phase 4

Conditions: Birth Asphyxia

Treatments: Drug: Vitamin E, Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT01743742

Antioxidants in Birth Asphyxia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 1 minute to 6 hours old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

Oral vitamin E, vitamin C

Experimental group

Description:

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

Treatment:

Drug: Vitamin E, Vitamin C