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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Birth Asphyxia

Intervention / Treatment
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* Drug: Vitamin E, Vitamin C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Apgar score of <6 at 5 minutes Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia) Exclusion Criteria Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth Gestational age <32 weeks. Lethal congenital anomaly

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 6 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral vitamin E, vitamin C<br>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<br> <br> * Other names: Tablet Limcee®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral vitamin C and Oral vitamin E