Single High Dose Vitamin C, E in Severe Birth Asphyxia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier:
NCT01743742
First received: November 29, 2012
Last updated: August 22, 2014
Last verified: August 2014
  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:


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: May 2013
Study Completion Date: October 2013
Primary Completion Date: September 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MD, PROF., 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: August 22, 2014
Health Authority: India: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014