RCT: Early Rehabilitation Protocol vs. Usual Care in the Pediatric ICU for Children With Acute Brain Injury
Condition: Pediatric Acute Neurologic Disease, Traumatic and Non-traumatic
MeSH terms: Brain Injuries; Nervous System Diseases
Study type: Interventional
Phase: Phase 2

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 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.
    


Intervention name(s): Early Rehabilitation Protocol; Usual care
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; acute neurologic disease; critical care; rehabilitation; outcome