Trial | NCT00624871  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ibuprofen vitamin c ...

  • Study Participants

    60
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 Started
Apr 30
2004
Primary Completion
Apr 30
2006
Study Completion
Apr 30
2006
Last Update
Feb 28
2008
Estimate

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

A Active Comparator

Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days

B Placebo Comparator

Infants will receive equivalent amount of placebo

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
No Results Posted