Single High Dose Vitamin C, E in Severe Birth Asphyxia
This study has been completed.
Sponsor:
Sir Takhtasinhji General Hospital
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
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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:
Drug Information available for:
Ascorbic acid
alpha-Tocopherol
Sodium ascorbate
Tocopherol
Vitamin E succinate
Tocopherol acetate
dl-alpha-Tocopherol
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:
|
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Apgar score of <6 at 5 minutes
- Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)
Exclusion Criteria
- Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
- Gestational age <32 weeks.
- 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 Asphyxia Neonatorum 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 16, 2013