NCT02381977

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
922

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

February 16, 2015

Last Update Submit

March 2, 2015

Conditions

Cardiac ArrestStrokeTraumatic Brain InjuryBrain MassStatus EpilepticusSpinal Cord DiseaseHydrocephalus

Outcome Measures

Primary Outcomes (1)

  • Prevalence of acute brain insult

    4 days over a 1 year period

Secondary Outcomes (1)

  • Mortality

    Hospital discharge or 3 months

Interventions

No interventionOTHER

Eligibility Criteria

Age7 Days - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Critically-ill children with acute neurologic injury

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart ArrestStrokeBrain Injuries, TraumaticStatus EpilepticusSpinal Cord DiseasesHydrocephalus

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSeizuresNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ericka Fink, MD, MS

    4126925164

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Pediatric Critical Care Medicine

Study Record Dates

First Submitted

February 16, 2015

First Posted

March 6, 2015

Study Start

November 1, 2011

Primary Completion

October 1, 2012

Study Completion

September 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03