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

Birth Asphyxia Clinical Trial

— CEBA  

Official title:

The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743742
• Other study ID #: Antioxidants in Birth Asphyxia
• Status: Completed
• Phase: Phase 4
• Start date: May 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2022
• Source: Sir Takhtasinhji General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Asphyxia
• Asphyxia Neonatorum
• Birth Asphyxia

Intervention

Drug:
• Vitamin E, Vitamin C

Locations

Country	Name	City	State
India	NICU, Sir T Hospital, Bhavnagar	Bhavnagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Sir Takhtasinhji General Hospital

Country where clinical trial is conducted

India, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic ischemic encephalopathy.	progression of birth asphyxia in terms of HIE Sarnat grading.	at 12 hours
Other	Role of single high dose vitamin E and vitamin C in progression or resolution of Hypoxic-ischemic encephalopathy.	Grading of HIE and discharge or death and sequel at followup.	15 days
Primary	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.	6 months
Secondary	Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.	Deaths and Sequel were measured.	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.