Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

• Status: Completed
• Trial end date: 2006-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Al-Azhar University
• Treatments: Ascorbic Acid; Ibuprofen; Vitamins

Criteria

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