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Completed

NCT Number: NCT00624871

Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

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.

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Key information

Conditions

Hypoxic Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Perinatal Asphyxia Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bab El-Shariya Hospital

Cairo, Cairo Governorate, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ascorbic acid (vitamin C)

Drug

IV, 100 mg/kg/day, every day, for 3 days

Ibuprofen

Drug

PO, 10 mg/kg on day 1, 5 mg/kg/day on days 2 and 3 of life

Placebo

Drug

Primary outcomes

  1. DDST-II

    Time frame: 6 months

  2. Neurological Examination

    Time frame: 6 months

Secondary outcomes

  1. Death

    Time frame: On Discharge

  2. Neurological Examination

    Time frame: On Discharge

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 28, 2008
Registry last updated
Feb 28, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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