Status:
COMPLETED
RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Patient-Centered Outcomes Research Institute
Conditions:
Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
Brief Summary
Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and ha...
Eligibility Criteria
Inclusion
- Children aged 3-17 years
- ABI due to TBI, ischemia, CNS infection / inflammation (i.e., meningitis, encephalitis), or cardiac arrest
- Subjects will be enrolled prior to 48 hours of PICU admission, have English or Spanish speaking parents/guardians, and en expected ICU stay ≥ 3 days
Exclusion
- Children with a do not resuscitate status
- Pediatric Cerebral Performance Category (PCPC) score 4-5 (4=severe disability and 5=persistent vegetative state) prior to ABI or are not expected to survive \> 24 hours will be excluded
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT02209935
Start Date
February 1 2015
End Date
August 31 2017
Last Update
September 6 2017
Active Locations (3)
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1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
3
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224