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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Primary Purpose

Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Ascorbic acid (vitamin C)

Ibuprofen

Placebo

About this trial

This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy focused on measuring Interleukin 1-beta, Interleukin 6, Vitamin C, HIE, neonates

Eligibility Criteria

undefined - 2 Hours (Child)All SexesDoes not accept 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

Sites / Locations

Bab El-Shariya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

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

Infants will receive equivalent amount of placebo

Outcomes

Primary Outcome Measures

DDST-II

Neurological Examination

Secondary Outcome Measures

Death

Neurological Examination

Full Information

NCT ID

NCT00624871

First Posted

February 20, 2008

Last Updated

February 27, 2008

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT00624871

Brief Title

Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

April 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Al-Azhar University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxic Ischemic Encephalopathy, Perinatal Asphyxia

Keywords

Interleukin 1-beta, Interleukin 6, Vitamin C, HIE, neonates

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm Description

Infants will receive equivalent amount of placebo

Intervention Type

Drug

Intervention Name(s)

Ascorbic acid (vitamin C)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

DDST-II

Time Frame

6 months

Title

Neurological Examination

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Death

Time Frame

On Discharge

Title

Neurological Examination

Time Frame

On Discharge

10. Eligibility

Sex

All

Maximum Age & Unit of Time

2 Hours

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Elsayed, MD

Organizational Affiliation

Al-Azhar University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laila Abd-Rabboh, MD

Organizational Affiliation

Al-Azhar University

Official's Role

Study Chair

Facility Information:

Facility Name

Bab El-Shariya Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

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Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

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