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

NCT01743742 | Completed Phase 4

• 1 other identifier: Antioxidants in Birth Asphyxia
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Birth Asphyxia

Keywords

Oral vitamin C and Oral vitamin E

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (2)

• Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.

  at 12 hours

• Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.

  15 days

Study Arms (1)

Oral vitamin E, vitamin C

EXPERIMENTAL

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

Interventions

Vitamin E, Vitamin C DRUG

Also known as: Evion® drops, Tablet Limcee®

Oral vitamin E, vitamin C

Eligibility Criteria

• Age: 1 Minute - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Apgar score of \<6 at 5 minutes
• Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)

You may not qualify if:

• Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
• Gestational age \<32 weeks.
• Lethal congenital anomaly

Sponsors & Collaborators

• Sir Takhtasinhji General Hospital: lead

Study Sites (1)

NICU, Sir T Hospital, Bhavnagar

Bhavnagar, Gujarat, 364002, India

Location

Related Publications (1)

• 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.

  PMID: 15724034 RESULT

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Vitamin E; Ascorbic Acid

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Jayendra R Gohil, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: December 6, 2012
• Study Start: May 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

IN (1)