Prevalence of Acute Critical Neurological Disease in Chil... | NCT02381977

Studies
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment

NCT02381977

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Mar 6, 2015Estimated

Enrollment

922Actual

Phase

Not provided

Conditions

Cardiac Arrest
Stroke
Traumatic Brain Injury
Brain Mass
Status Epilepticus
Spinal Cord Disease
Hydrocephalus

Interventions

No intervention

Countries

Not provided

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

Mar 2015

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

Nov 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Sep 2014Actual

First Submitted Date

Feb 16, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 6, 2015Estimated

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

Mar 2, 2015

Last Update Posted Date

Mar 6, 2015Estimated

Name	Class
Laerdal Medical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

922Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of acute brain insult		4 days over a 1 year period

Secondary Outcomes

Measure	Description	Time Frame
Mortality		Hospital discharge or 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).
Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.
Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.

Exclusion Criteria:

Children with acute perinatal neurologic disease.
Children with isolated chronic brain injury and no acute neurologic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Days

Maximum Age

17 Years

Standard Ages

Child

Study Population

Critically-ill children with acute neurologic injury

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Ericka Fink, MD, MS	4126925164	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D020521	Stroke
D000070642	Brain Injuries, Traumatic
D013226	Status Epilepticus
D013118	Spinal Cord Diseases
D006849	Hydrocephalus

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided