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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624871
First Posted: February 28, 2008
Last Update Posted: February 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Al-Azhar University
  Purpose
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: Quadruple (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624871


Locations
Egypt
Bab El-Shariya Hospital
Cairo, Egypt
Sponsors and Collaborators
Al-Azhar University
Investigators
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
ClinicalTrials.gov Identifier: NCT00624871     History of Changes
Other Study ID Numbers: 2004-MD-thesis-ahmed
First Submitted: February 20, 2008
First Posted: February 28, 2008
Last Update Posted: February 28, 2008
Last Verified: February 2008

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

Additional relevant MeSH terms:
Ischemia
Brain Diseases
Hypoxia
Brain Ischemia
Hypoxia-Ischemia, Brain
Asphyxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Death
Wounds and Injuries
Vitamins
Ascorbic Acid
Ibuprofen
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents