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

Primary Purpose

Birth Asphyxia

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Vitamin E, Vitamin C
Sponsored by
Sir Takhtasinhji General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Asphyxia focused on measuring Oral vitamin C and Oral vitamin E

Eligibility Criteria

1 Minute - 6 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NICU, Sir T Hospital, Bhavnagar

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral vitamin E, vitamin C

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Vitamin C and E were initiated orally within 6 hours of birth.

Secondary Outcome Measures

Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.
Deaths and Sequel were measured.

Full Information

First Posted
November 29, 2012
Last Updated
July 4, 2022
Sponsor
Sir Takhtasinhji General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01743742
Brief Title
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
Acronym
CEBA
Official Title
The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Takhtasinhji General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Asphyxia
Keywords
Oral vitamin C and Oral vitamin E

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral vitamin E, vitamin C
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vitamin E, Vitamin C
Other Intervention Name(s)
Evion® drops, Tablet Limcee®
Primary Outcome Measure Information:
Title
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.
Description
Vitamin C and E were initiated orally within 6 hours of birth.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.
Description
Deaths and Sequel were measured.
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 Pre-specified Outcome Measures:
Title
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.
Description
progression of birth asphyxia in terms of HIE Sarnat grading.
Time Frame
at 12 hours
Title
Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.
Description
Grading of HIE and discharge or death and sequel at followup.
Time Frame
15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayendra R Gohil, MD
Organizational Affiliation
Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
NICU, Sir T Hospital, Bhavnagar
City
Bhavnagar
State/Province
Gujarat
ZIP/Postal Code
364002
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
15724034
Citation
Darlow BA, Buss H, McGill F, Fletcher L, Graham P, Winterbourn CC. Vitamin C supplementation in very preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2005 Mar;90(2):F117-22. doi: 10.1136/adc.2004.056440.
Results Reference
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First-day High Dose Vitamin C, E in Severe Birth Asphyxia

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