- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02381977
Prevalence of Acute Critical Neurological Disease in Children: a Global Epidemiological Assessment (PANGEA)
March 2, 2015 updated by: Ericka Fink, University of Pittsburgh
PANGEA is an international prospective point prevalence study to describe the epidemiology, interventions, and outcomes in children with acute critical brain disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
922
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
1 week to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Critically-ill children with acute neurologic injury
Description
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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of acute brain insult
Time Frame: 4 days over a 1 year period
|
4 days over a 1 year period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: Hospital discharge or 3 months
|
Hospital discharge or 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ericka Fink, MD, MS, 4126925164
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
November 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
February 16, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 6, 2015
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PANGEA
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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