Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Not Applicable
Completed
- Conditions
- Hypoxic Ischemic EncephalopathyPerinatal Asphyxia
- Interventions
- Registration Number
- NCT00624871
- Lead Sponsor
- Al-Azhar University
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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
Exclusion Criteria
- Major congenital anomalies
- Early sepsis
- Gastrointestinal bleeding
- Thrombocytopenia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Ascorbic acid (vitamin C) Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days A Ibuprofen Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days B Placebo Infants will receive equivalent amount of placebo
- Primary Outcome Measures
Name Time Method DDST-II 6 months Neurological Examination 6 months
- Secondary Outcome Measures
Name Time Method Death On Discharge Neurological Examination On Discharge
Trial Locations
- Locations (1)
Bab El-Shariya Hospital
🇪🇬Cairo, Egypt