Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy - Full Text View

Sponsor:	Al-Azhar University
Information provided by:	Al-Azhar University
ClinicalTrials.gov Identifier:	NCT00624871

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:

MedlinePlus related topics: Vitamin C

Drug Information available for: Ascorbic acid Ibuprofen

U.S. FDA Resources

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

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:

Asphyxia
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Hypoxia-Ischemia, Brain
Death
Pathologic Processes
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases

ClinicalTrials.gov processed this record on February 09, 2012