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COMPLETEDNA

Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Ascorbic Acid Combined With Ibuprofen in Hypoxic Ischemic Encephalopathy: A Randomized Controlled Trial.

NCT00624871•Al-Azhar University

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Bab El-Shariya Hospital

Cairo, Cairo Governorate, Egypt

Key Dates

Start Date

April 1, 2004

Primary Completion Date

April 1, 2006

Completion Date

April 1, 2006

Last Updated

February 28, 2008

Enrollment

ACTUAL participants

Conditions

Hypoxic Ischemic EncephalopathyPerinatal Asphyxia

Interventions

Ascorbic acid (vitamin C)

DRUG

Ibuprofen

DRUG

Placebo

DRUG

Cool Prime Comparative Effectiveness Study for Mild HIE

NCT04621279

Mild Hypoxic Ischemic Encephalopathy of Newborn

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NOT_YET_RECRUITING

Neonates with Hypoxic Ischemic Encephalopathy (HIE)

NCT06694545

Hypoxic Ischemic Encephalopathy (HIE)

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NOT_YET_RECRUITINGNA

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

NCT06447155

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Inclusion Criteria

Exclusion Criteria

Cool Prime Comparative Effectiveness Study for Mild HIE

Neonates with Hypoxic Ischemic Encephalopathy (HIE)

Continuous Versus Bolus Feeding in Neonates With Hypoxic Ischemic Encephalopathy

Optimization of Routine Obstetric and Neonatal Care in the Management of Severe Perinatal Asphyxia in Term or Near-term Newborns: Analysis of Sub-optimal Care

Radiological Evaluation of Hypoxic Ischemic Encephalopathy

Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia