drugset / Trial / NCT00624871

Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

NCT00624871

Completed 60 enrolled Al-Azhar University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2004-04
Primary completion
2006-04
Completion
2006-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 5 mg/kg Oral
Comparator Vitamin C Other / unclassified 100 mg/kg Intravenous