Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Al-Azhar University

Status: Completed

Conditions: Perinatal Asphyxia; Hypoxic Ischemic Encephalopathy

Treatments: Drug: Ascorbic acid (vitamin C); Drug: Ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00624871

2004-MD-thesis-ahmed

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: Under 2 hours old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days

Treatment:

Drug: Ibuprofen

Drug: Ascorbic acid (vitamin C)

B

Placebo Comparator group

Description:

Infants will receive equivalent amount of placebo

Treatment:

Drug: Placebo