Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

• Sponsor: Al-Azhar University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00624871
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Hypoxic Ischemic Encephalopathy; Perinatal Asphyxia	Drug: Ascorbic acid (vitamin C); Drug: Ibuprofen; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• 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.
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Apr 1, 2006
• Actual Study Completion Date: Apr 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. DDST-II [6 months]

2. Neurological Examination [6 months]

Secondary Outcome Measures

1. Death [On Discharge]

2. Neurological Examination [On Discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Hours
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00624871
• Other Study ID Numbers: 2004-MD-thesis-ahmed
• First Posted: Feb 28, 2008
• Last Update Posted: Feb 28, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Interleukin 1-beta; Interleukin 6; Vitamin C; HIE; neonates
• Additional relevant MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia; Asphyxia; Ascorbic Acid; Ibuprofen

Study Results

No Results Posted as of Feb 28, 2008