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

NCT ID: NCT01743742

Last Updated: 2022-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-10-31

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.

Conditions

Birth Asphyxia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Oral vitamin E, vitamin C

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

Group Type: EXPERIMENTAL

Vitamin E, Vitamin C

Intervention Type: DRUG

Interventions

Vitamin E, Vitamin C

Intervention Type: DRUG

Other Intervention Names

Evion® drops; Tablet Limcee®

Eligibility 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

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 6 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Takhtasinhji General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jayendra R. Gohil, MD, PROF.

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jayendra R Gohil, MD

Role: PRINCIPAL_INVESTIGATOR

Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India

Locations

NICU, Sir T Hospital, Bhavnagar

Bhavnagar, Gujarat, India

Countries

India

References

Darlow BA, Buss H, McGill F, Fletcher L, Graham P, Winterbourn CC. Vitamin C supplementation in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F117-22. doi: 10.1136/adc.2004.056440.

Reference Type: RESULT

PMID: 15724034 (View on PubMed)

Other Identifiers

Antioxidants in Birth Asphyxia

Identifier Type: -

Identifier Source: org_study_id