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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
  • Neurological Examination [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: On Discharge ] [ Designated as safety issue: Yes ]
  • Neurological Examination [ Time Frame: On Discharge ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 2 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ahmed Helal Elsayed, Al-Azhar University
ClinicalTrials.gov Identifier: NCT00624871     History of Changes
Other Study ID Numbers: 2004-MD-thesis-ahmed
Study First Received: February 20, 2008
Last Updated: February 27, 2008
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Hypoxia, Brain
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Ascorbic Acid
Ibuprofen
Vitamins
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antioxidants
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 20, 2014