RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
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 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.
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