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Trial record 1 of 19 for:    "Asphyxia neonatorum"
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Single High Dose Vitamin C, E in Severe Birth Asphyxia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jayendra R. Gohil, Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier:
NCT01743742
First received: November 29, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

To study the role of single high dose vitamin E and vitamin C in hypoxic ischemic encephalopathy in newborns, in reduction of morbidity and adverse neurodevelopmental sequelae.


Condition Intervention Phase
Birth Asphyxia
 Drug: Vitamin E, Vitamin C
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Single High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia)in Newborns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sir Takhtasinhji General Hospital:

Primary Outcome Measures:
  • To assess the role of single high dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequelae in newborns with birth asphyxia. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy. [ Time Frame: at 12 hours ] [ Designated as safety issue: No ]
  • Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy. [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Drug: Vitamin E, Vitamin C
Other Names:
  • Evion drops
  • Tablet Limcee

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743742

Locations
India
NICU, Sir T Hospital, Bhavnagar
Bhavnagar, Gujarat, India, 364002
Sponsors and Collaborators
Sir Takhtasinhji General Hospital
Investigators
Principal Investigator: Jayendra R Gohil, MD Professor of Pediatrics, Dept of Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
  More Information

Publications:

Responsible Party: Jayendra R. Gohil, Professor of Pediatrics, Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier: NCT01743742     History of Changes
Other Study ID Numbers: Antioxidants in Birth Asphyxia
Study First Received: November 29, 2012
Last Updated: December 4, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Sir Takhtasinhji General Hospital:
Oral vitamin E and vitamin C

Additional relevant MeSH terms:
Asphyxia Neonatorum
Asphyxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Hypoxia, Brain
Ascorbic Acid
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013