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Single High Dose Vitamin C, E in Severe Birth Asphyxia

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ClinicalTrials.gov Identifier: NCT01743742
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : August 25, 2014
Sponsor:
Information provided by (Responsible Party):
Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Birth Asphyxia Drug: Vitamin E, Vitamin C Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Single High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia)in Newborns
Study Start Date : May 2013
Primary Completion Date : September 2013
Study Completion Date : October 2013


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]

Other Outcome Measures:
  1. Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy. [ Time Frame: at 12 hours ]
  2. Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy. [ Time Frame: 15 days ]


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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014

Keywords provided by Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital:
Oral vitamin E and vitamin C

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