Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic Clinical Trial
Official title:
RCT Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
| Verified date | September 2017 |
| Source | University of Pittsburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 Scale (VABS)
pre-ABI and 6 months post-ABI. This test, validated for children, assesses a child's physical
and cognitive function as well as behavior. Other tests will be performed that assesses child
and family quality of life and length of hospital admission. Our outcome tests were chosen
because 1) They are the most important outcomes to families of children as surveyed in our
ICU and 2) They are outcomes that can be influenced by ERP.
Summary. This is the first and largest study designed to evaluate whether ERP improves
outcomes for critically ill children with ABI. We anticipate that rehabilitation practices in
ICUs will be unprotocolized and under-utilized. We expect that patients in the ERP group will
have superior adaptive and quality of life outcomes, outcomes important to families, without
increasing adverse events compared to patients in the usual care group.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | August 31, 2017 |
| Est. primary completion date | August 31, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
| United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
| United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pittsburgh | Patient-Centered Outcomes Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Vineland Adaptive Behavioral Scale score | 6 months |