Birth AsphyxiaPhase 4CEBANCT01743742
First-day High Dose Vitamin C, E in Severe Birth Asphyxia
A Phase 4 study testing Vitamin E, Vitamin C in people with Birth Asphyxia, run by Sir Takhtasinhji General Hospital at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 6 hours
- Conditions the study is for
- Birth Asphyxia
- What is being tested?
- Vitamin E, Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIndia
- Study dates
- May 2013to Oct 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apgar score of <6 at 5 minutes
- Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)
Who cannot join
- Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
- Gestational age <32 weeks.
- Lethal congenital anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns
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.
Read the 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.
- Conditions
- Birth Asphyxia
- Being tested
- Vitamin E, Vitamin C
- Keywords
- Oral vitamin C and Oral vitamin E
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin E, Vitamin CDrug
Also called Evion® drops, Tablet Limcee®
| Study group | Role | What they receive |
|---|---|---|
| Oral vitamin E, vitamin C | Experimental | 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 Receives: Drug: Vitamin E, Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Mortality and morbidity in newborns with birth asphyxia administered vitamin E and vitamin C.
Deaths and Sequel were measured.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth AsphyxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Takhtasinhji General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jayendra R. Gohil, MD, PROF., Sir Takhtasinhji General Hospital
- Investigators
- Jayendra R Gohil, MD, Principal investigator, Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743742
- Sponsor's protocol ID
- Antioxidants in Birth Asphyxia
- Acronym
- CEBA
- Status last verified
- Jul 2022
- First submitted
- 29 Nov 2012
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15724034
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First-day High Dose Vitamin E and Vitamin C in Hypoxic Ischemic Encephalopathy (Following Birth Asphyxia) in Newborns
- ClinicalTrials.gov ID
- NCT01743742
- Acronym / sponsor ID
- CEBA / Antioxidants in Birth Asphyxia
- Conditions
- Birth Asphyxia
- Keywords
- Oral vitamin C and Oral vitamin E
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Sir Takhtasinhji General HospitalOther government
- Study start
- May 2013 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral vitamin E, vitamin C | Experimental | Drug: Vitamin E, Vitamin CSingle 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 |
Who may qualify
- Ages
- 1 minute to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Apgar score of <6 at 5 minutes
- Clinical features suggestive of neonatal encephalopathy (coma, seizures or hypotonia)
Key exclusion criteria (3 listed)
- Newborn hospitalized in neonatal intensive care unit (NICU) after 6 hours of birth
- Gestational age <32 weeks.
- Lethal congenital anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E, Vitamin CAlso: Evion® drops, Tablet Limcee® | Drug | Oral vitamin E, vitamin C |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Results publication: PubMed 15724034Darlow 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.
Related trials for Birth Asphyxia
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
RecruitingPhase 2
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia
Neonatal Encephalopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayendra R Gohil, MD principal investigator
Professor Pediatrics, Govt Medical College, Bhavnagar, Gujarat, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin E, Vitamin C in people with Birth Asphyxia, run by Sir Takhtasinhji General Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.