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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

NCT00624871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-02-28

No results posted yet for this study

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.

Conditions

  • Hypoxic Ischemic Encephalopathy
  • Perinatal Asphyxia

Interventions

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

DRUG

Placebo

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Ahmed Elsayed, MD · Al-Azhar University

  • Laila Abd-Rabboh, MD · Al-Azhar University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
2 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-04-30
Completion
2006-04-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00624871 on ClinicalTrials.gov