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NCT02209935 · ClinicalTrials.gov registry record · Phase 2
RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
A Phase 2 study of Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
- 3
- Study locations
NCT02209935 is a Phase 2 study of Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic that has completed, run by University of Pittsburgh. The registered enrollment target is 58 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT02209935, a Phase 2 study of Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
- 3
- Study locations
Study 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 have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ill children with acute brain injury (ABI) are at increased risk of life-long disability and stunted development, benefits of ERP for this group have not been studied and are not standard of care in pediatric ICUs. Objectives. The aims of this study are 1) To better understand current practices and barriers to use of these therapies and 2) To subsequently evaluate ERP vs. usual care in children with ABI in the ICU by randomizing children to these groups and measuring outcomes. We expect that ERP therapies are underutilized in the PICU and that outcomes in the ERP group will be superior compared to the usual care group. Methods. The first task of this research program is to survey healthcare professionals (physicians, nurses, allied health) and families of children in the ICU about their hospital's resources, current practices, and barriers to ERP. This survey will be distributed to the 78 sites affiliated with the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), a group of clinicians and researchers dedicated to improving child outcomes from critical illness. Next, we will enroll 175 children with ABI in a randomized, controlled trial of ERP versus usual care. Children enrolled in ERP will begin therapies by 48 hours of ICU admission and those in the usual care group will begin therapies when these services are ordered by treating physicians. Children aged 3-17 years with ABI expected to be admitted to the ICU \> 48 hours due to trauma, infection, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child's clinical status. The effectiveness of ERP will be measured using the Vineland Behavior Adaptive Sc
Conditions Studied
Interventions
- OTHER Usual care
- OTHER Early Rehabilitation Protocol
Study Locations (3)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Pennsylvania
- Children's Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-02 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02209935
The ClinicalTrials.gov registry entry for NCT02209935 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic appearing as the primary indexed condition, and to 2 interventions - of which Usual care is the first listed.
NCT02209935 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Ohio, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02209935 about?
NCT02209935 is a clinical study titled "RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury". Background. Early rehabilitation programs (ERP) that include physical, occupational, and speech therapies lessens debilitation and promotes return to previous physical and cognitive functioning and have been successfully applied in adult intensive care units (ICUs). Despite the fact that critically ...
What is the current status of trial NCT02209935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2015-02. Estimated completion is 2017-08-31.
What conditions does trial NCT02209935 study?
This clinical trial studies the following conditions: Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic.
What interventions are being tested in trial NCT02209935?
The interventions under investigation include: Usual care (OTHER), Early Rehabilitation Protocol (OTHER).
Who is sponsoring clinical trial NCT02209935?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02209935 being conducted?
This trial has 3 study locations across Illinois, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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