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

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ClinicalTrials.gov Identifier: NCT01743742
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital

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.

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

Detailed Description:

Design: A prospective, randomized controlled trial over 5 months. Patients: Newborns admitted within 6 hours after birth with gestation >32 weeks, Apgar score of <6 at 5 minutes, features suggestive of neonatal encephalopathy.

Intervention: After randomization, Group A newborns received oral vitamin C 250 mg once a day within a 24-hour interval along with a single dose of vitamin E 200 IU. Group B newborns received no intervention.

Outcome measures: Severity and progression of birth asphyxia, duration of hospitalization and mechanical ventilation, mortality, and neurodevelopmental outcome.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns
Actual Study Start Date : May 2013
Actual Primary Completion Date : September 2013
Actual 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 first day high-dose vitamin E and vitamin C in reduction of adverse neurodevelopmental sequel in newborns with birth asphyxia. [ Time Frame: 6 months ]
    Vitamin C and E were initiated orally within 6 hours of birth.


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. ]
    Deaths and Sequel were measured.


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 ]
    progression of birth asphyxia in terms of HIE Sarnat grading.

  2. Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy. [ Time Frame: 15 days ]
    Grading of HIE and discharge or death and sequel at followup.



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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
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India
NICU, Sir T Hospital, Bhavnagar
Bhavnagar, Gujarat, India, 364002
Sponsors and Collaborators
Sir Takhtasinhji General Hospital
Investigators
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Principal Investigator: Jayendra R Gohil, MD Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
Publications of Results:
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Responsible Party: Jayendra R. Gohil, MD, PROF., Professor of Pediatrics, Sir Takhtasinhji General Hospital
ClinicalTrials.gov Identifier: NCT01743742    
Other Study ID Numbers: Antioxidants in Birth Asphyxia
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Keywords provided by Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital:
Oral vitamin C and Oral vitamin E
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases
Vitamins
Ascorbic Acid
Vitamin E
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents