Official Title: “Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2006

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
• Placebo Comparator: B
  • Infants will receive equivalent amount of placebo

Primary Measures

• DDST-II
  • Time Frame: 6 months
    Safety Issue?: No
• Neurological Examination
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Death
  • Time Frame: On Discharge
    Safety Issue?: Yes
• Neurological Examination
  • Time Frame: On Discharge
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 2 Hours

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Al-Azhar University

Overall Clinical Trial Officials and Contacts

Ahmed Elsayed, MD Principal Investigator Al-Azhar University  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00624871

Study ID Number: 2004-MD-thesis-ahmed

ClinicalTrials.gov Identifier: NCT00624871

Health Authority: Egypt: Institutional Review Board