Hypoxic Ischemic EncephalopathyNCT00624871
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
A study testing Ascorbic acid (vitamin C) and Ibuprofen in people with Hypoxic Ischemic Encephalopathy and Perinatal Asphyxia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. Read more about this study
- Who is it for?
- Ages Up to 2 hours
- Conditions the study is for
- Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia
- What is being tested?
- Ascorbic acid (vitamin C) and Ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2004to Apr 2006
- Phase
- Interventional
- 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 Up to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Apgar score at 5 minutes < 6
- Profound metabolic or mixed acidosis with pH < 7 in the initial blood gas
- Evidence of encephalopathy such as coma, seizures or hypotonia
- Evidence of multi-system compromise, in addition to encephalopathy
Who cannot join
- Major congenital anomalies
- Early sepsis
- Gastrointestinal bleeding
- Thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.
- Being tested
- Ascorbic acid (vitamin C), Ibuprofen, Placebo
- Keywords
- Interleukin 1-beta, Interleukin 6, Vitamin C, HIE, neonates
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acid (vitamin C)Drug
IV, 100 mg/kg/day, every day, for 3 days
IbuprofenDrug
PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days Receives: Drug: Ascorbic acid (vitamin C); Drug: Ibuprofen |
| B | Placebo comparator | Infants will receive equivalent amount of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
DDST-II
Measured: 6 months
Neurological Examination
Measured: 6 months
Secondary outcomes (2)
Death
Measured: On Discharge
Neurological Examination
Measured: On Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startApr 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Ischemic EncephalopathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Investigators
- Ahmed Elsayed, MD, Principal investigator, Al-Azhar UniversityLaila Abd-Rabboh, MD, Study chair, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624871
- Sponsor's protocol ID
- 2004-MD-thesis-ahmed
- Status last verified
- Feb 2008
- First submitted
- 20 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00624871
- Acronym / sponsor ID
- 2004-MD-thesis-ahmed
- Keywords
- Interleukin 1-beta, Interleukin 6, Vitamin C, HIE, neonates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 28 Feb 2008 (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.
Oxygen radicals and inflammation are important causes for brain injury in neonates following perinatal asphyxia. Animal studies demonstrated potential benefits to the brain when using both of vitamin C and ibuprofen. The efficacy of these 2 drugs when combined in protecting the human brain has not been studied. We aimed in this study to test the hypothesis that a combination of anti-oxidants (vitamin C) and anti-inflammatory (ibuprofen) drugs can decrease the brain injury in perinatal asphyxia and improve outcomes when given to infants immediately after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Ascorbic acid (vitamin C), Drug: IbuprofenInfants will receive intravenous ascorbic acid and oral ibuprofen for 3 days |
| B | Placebo comparator | Drug: PlaceboInfants will receive equivalent amount of placebo |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Apgar score at 5 minutes < 6
- Profound metabolic or mixed acidosis with pH < 7 in the initial blood gas
- Evidence of encephalopathy such as coma, seizures or hypotonia
- Evidence of multi-system compromise, in addition to encephalopathy
Key exclusion criteria (4 listed)
- Major congenital anomalies
- Early sepsis
- Gastrointestinal bleeding
- Thrombocytopenia
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 |
|---|---|---|
| Ascorbic acid (vitamin C)IV, 100 mg/kg/day, every day, for 3 days | Drug | A |
| IbuprofenPO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life | Drug | A |
| Placebo | Drug | B |
Primary outcome
DDST-II
Time frame: 6 months
Neurological Examination
Time frame: 6 months
2 secondary outcomes
Death
Time frame: On Discharge
Neurological Examination
Time frame: On Discharge
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 28 Feb 2008.
Related trials for Hypoxic Ischemic Encephalopathy
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
RecruitingPhase 2
The PROTECT-HIE Pilot Trial
Hypoxic-ischemic Encephalopathy (HIE)
RecruitingPhase 2
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures
Neonatal Seizure, Neonatal Encephalopathy
RecruitingObservational study
Continuous Monitoring of Body Temperature in Neonates During Therapeutic Hypothermia
Therapeutic Hypothermia, Neonatal Hypoxic-Ischemic Encephalopathy
Not yet recruitingObservational study
Newborn Brain Assessment - CergenX Wave
Neonatal Encephalopathy, Neonatal Encephalopathy (Neonatal Hypoxic-ischemic 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.
Ahmed Elsayed, MD principal investigator
Al-Azhar University
Laila Abd-Rabboh, MD study chair
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ascorbic acid (vitamin C) and Ibuprofen in people with Hypoxic Ischemic Encephalopathy and Perinatal Asphyxia, run by Al-Azhar University at 1 site in Egypt.
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 4 inclusion and 4 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 28 Feb 2008. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
DDST-II (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2008; AzTrials last refreshed its copy on 31 Oct 2026.