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
|Condition or disease||Intervention/treatment||Phase|
|Birth Asphyxia||Drug: Vitamin E, Vitamin C||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
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
|NICU, Sir T Hospital, Bhavnagar|
|Bhavnagar, Gujarat, India, 364002|
|Principal Investigator:||Jayendra R Gohil, MD||Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India|