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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01743742

Acronym

CEBA

Enrollment

Registered

2012-12-06

Start date

2013-05-31

Completion date

2013-10-31

Last updated

2022-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Asphyxia

Keywords

Oral vitamin C and Oral vitamin E

Brief 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.

Interventions

DRUGVitamin E, Vitamin C

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 6 Hours

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	6 months	Vitamin C and E were initiated orally within 6 hours of birth.

Secondary

Measure	Time frame	Description
Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.	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.	Deaths and Sequel were measured.

Other

Measure	Time frame	Description
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.	at 12 hours	progression of birth asphyxia in terms of HIE Sarnat grading.
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.	15 days	Grading of HIE and discharge or death and sequel at followup.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026