Trials / Completed
CompletedNCT00624871
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Al-Azhar University · Academic / Other
- Sex
- All
- Age
- 2 Hours
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DRUG | Placebo |
Timeline
- Start date
- 2004-04-01
- Primary completion
- 2006-04-01
- Completion
- 2006-04-01
- First posted
- 2008-02-28
- Last updated
- 2008-02-28
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT00624871. Inclusion in this directory is not an endorsement.