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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

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

Condition Intervention
Hypoxic Ischemic Encephalopathy Perinatal Asphyxia Drug: Ascorbic acid (vitamin C) Drug: Ibuprofen Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by Al-Azhar University:

Primary Outcome Measures:
  • DDST-II [ Time Frame: 6 months ]
  • Neurological Examination [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Death [ Time Frame: On Discharge ]
  • Neurological Examination [ Time Frame: On Discharge ]

Enrollment: 60
Study Start Date: April 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days
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
Placebo Comparator: B
Infants will receive equivalent amount of placebo
Drug: Placebo


Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00624871

Bab El-Shariya Hospital
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University
Principal Investigator: Ahmed Elsayed, MD Al-Azhar University
Study Chair: Laila Abd-Rabboh, MD Al-Azhar University
  More Information

Responsible Party: Ahmed Helal Elsayed, Al-Azhar University Identifier: NCT00624871     History of Changes
Other Study ID Numbers: 2004-MD-thesis-ahmed
Study First Received: February 20, 2008
Last Updated: February 27, 2008

Keywords provided by Al-Azhar University:
Interleukin 1-beta
Interleukin 6
Vitamin C

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Ascorbic Acid
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 22, 2017