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| Sponsored by: |
Al-Azhar University |
|---|---|
| Information provided by: | Al-Azhar University |
| ClinicalTrials.gov Identifier: | NCT00624871 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypoxic Ischemic Encephalopathy Perinatal Asphyxia |
Drug: Ascorbic acid (vitamin C) Drug: Ibuprofen Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial. |
| Enrollment: | 60 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | April 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
|
Drug: Ascorbic acid (vitamin C)
IV, 100 mg/kg/day, every day, for 3 days
Drug: Ibuprofen
PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
|
|
B: Placebo Comparator
Infants will receive equivalent amount of placebo
|
Drug: Placebo |
Eligibility| Ages Eligible for Study: | up to 2 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Egypt | |
| Bab El-Shariya Hospital | |
| Cairo, Egypt | |
| Principal Investigator: | Ahmed Elsayed, MD | Al-Azhar University |
| Study Chair: | Laila Abd-Rabboh, MD | Al-Azhar University |
More Information
| Responsible Party: | Al-Azhar University ( Ahmed Helal Elsayed ) |
| Study ID Numbers: | 2004-MD-thesis-ahmed |
| Study First Received: | February 20, 2008 |
| Last Updated: | February 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00624871 |
| Health Authority: | Egypt: Institutional Review Board |
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Interleukin 1-beta Interleukin 6 Vitamin C HIE neonates |
|
Liver Diseases Death Neurotoxicity Syndromes Hypoxia, Brain Brain Damage, Chronic Disorders of Environmental Origin Brain Diseases Cerebrovascular Disorders Signs and Symptoms Hypoxia-Ischemia, Brain Mental Disorders Brain Ischemia Brain Injuries Dementia Neurobehavioral Manifestations |
Hepatic Insufficiency Delirium Liver Failure Ibuprofen Metabolic Diseases Neurotoxicity syndromes Poisoning Wounds and Injuries Vascular Diseases Central Nervous System Diseases Confusion Ischemia Encephalitis Cognition Disorders Virus Diseases |
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Anti-Inflammatory Agents Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Cyclooxygenase Inhibitors Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Central Nervous System Viral Diseases Protective Agents Pharmacologic Actions Pathologic Processes |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Vitamins Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Micronutrients Antirheumatic Agents Central Nervous System Agents |
