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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

This study has been completed.
Sponsor:
Information provided by:
Al-Azhar University
ClinicalTrials.gov Identifier:
NCT00624871
First received: February 20, 2008
Last updated: February 27, 2008
Last verified: February 2008

February 20, 2008
February 27, 2008
April 2004
April 2006   (final data collection date for primary outcome measure)
  • DDST-II [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Neurological Examination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00624871 on ClinicalTrials.gov Archive Site
  • Death [ Time Frame: On Discharge ] [ Designated as safety issue: Yes ]
  • Neurological Examination [ Time Frame: On Discharge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hypoxic Ischemic Encephalopathy
  • Perinatal Asphyxia
  • 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
  • Active Comparator: A
    Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
    Interventions:
    • Drug: Ascorbic acid (vitamin C)
    • Drug: Ibuprofen
  • Placebo Comparator: B
    Infants will receive equivalent amount of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
up to 2 Hours
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00624871
2004-MD-thesis-ahmed
Yes
Ahmed Helal Elsayed, Al-Azhar University
Al-Azhar University
Not Provided
Principal Investigator: Ahmed Elsayed, MD Al-Azhar University
Study Chair: Laila Abd-Rabboh, MD Al-Azhar University
Al-Azhar University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP