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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02381977
Other study ID # PANGEA
Secondary ID
Status Completed
Phase N/A
First received February 16, 2015
Last updated March 2, 2015
Start date November 2011
Est. completion date September 2014

Study information

Verified date March 2015
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 922
Est. completion date September 2014
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

1. Children aged 7 days to 17 years inclusively and admitted to an ICU (ICU can be classified as general, cardiac, trauma, etc).

2. Children with acute or acute on chronic neurologic disease that occurred just prior to hospital admission or occurred during the hospital admission.

3. Acute neurologic disease is secondary to TBI, stroke, brain mass, hydrocephalus, cardiac arrest, status epilepticus, CNS infection/inflammation, or spinal cord injury.

Exclusion Criteria:

1. Children with acute perinatal neurologic disease.

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

Study Design

Time Perspective: Cross-Sectional


Intervention

Other:
No intervention


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh Laerdal Medical

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of acute brain insult 4 days over a 1 year period No
Secondary Mortality Hospital discharge or 3 months No
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