Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

February 27, 2008 updated by: Al-Azhar University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Bab El-Shariya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 hours (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
DDST-II
Time Frame: 6 months
6 months
Neurological Examination
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: On Discharge
On Discharge
Neurological Examination
Time Frame: On Discharge
On Discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Ahmed Elsayed, MD, Al-Azhar University
  • Study Chair: Laila Abd-Rabboh, MD, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

February 20, 2008

First Submitted That Met QC Criteria

February 27, 2008

First Posted (Estimate)

February 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 28, 2008

Last Update Submitted That Met QC Criteria

February 27, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004-MD-thesis-ahmed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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