Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ische... | NCT00624871

Studies
Ascorbic Acid and Ibuprofen in Infants With Hypoxic Ischemic Encephalopathy

NCT00624871

Sponsor

Al-Azhar University

Status

Completed

Last Update Posted

Feb 28, 2008Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Hypoxic Ischemic Encephalopathy
Perinatal Asphyxia

Interventions

Ascorbic acid (vitamin C)
Ibuprofen
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Feb 20, 2008

First Submission Date that Met QC Criteria

Feb 27, 2008

First Posted Date

Feb 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2008

Last Update Posted Date

Feb 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Infants will receive intravenous ascorbic acid and oral ibuprofen for 3 days	Drug: Ascorbic acid (vitamin C) Drug: Ibuprofen
B	Placebo Comparator	Infants will receive equivalent amount of placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ascorbic acid (vitamin C)	Drug	IV, 100 mg/kg/day, every day, for 3 days	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DDST-II		6 months
Neurological Examination		6 months

Secondary Outcomes

Measure	Description	Time Frame
Death		On Discharge
Neurological Examination		On Discharge

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Elsayed, MD	Al-Azhar University	Principal Investigator
Laila Abd-Rabboh, MD	Al-Azhar University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bab El-Shariya Hospital		Cairo	Cairo Governorate		Egypt

Condition Browse Module

MeSH Terms

ID	Term
D020925	Hypoxia-Ischemia, Brain

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid
D007052	Ibuprofen

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided