Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624871
• Other study ID #: 2004-MD-thesis-ahmed
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: February 27, 2008
• Start date: April 2004
• Est. completion date: April 2006

Study information

• Verified date: February 2008
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia
• Perinatal Asphyxia

Intervention

Drug:
• Ascorbic acid (vitamin C)
IV, 100 mg/kg/day, every day, for 3 days
• Ibuprofen
PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life
• Placebo

Locations

Country	Name	City	State
Egypt	Bab El-Shariya Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DDST-II		6 months	No
Primary	Neurological Examination		6 months	No
Secondary	Death		On Discharge	Yes
Secondary	Neurological Examination		On Discharge	No