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Early vs. Usual Care Rehabilitation for Children with Acute Brain Injury in the ICU: an RCT

PI: Ericka L. Fink, MD, MS

Funding: PCORI Grant CER-1310-08343

Background: Disability after critical illness is increasing as survival has increased. Provision of early mobility and cognition interventions helps critically ill adults return to their previous state of functioning. There are little data to support these interventions in critically ill children, and those presenting with newly acquired brain injuries are at increased risk of disability.

Objectives: The aims of this study are (1) to better understand current practices and barriers to use of these therapies in pediatric ICUs, and (2) to evaluate early vs. usual care rehabilitation interventions in children with brain injuries in the ICU in a multicenter, randomized clinical trial. Our hypothesis is that functional outcomes at 6 months in the early rehabilitation group will be superior compared to the usual care group.

Methods: The first aim will be assessed using an electronic  survey healthcare professionals (physicians, nurses, allied health) and families of children in ICUs about their hospital’s resources, current practices, and barriers to ICU rehabilitation. This survey will be distributed internationally to the PANGEA sites (www.pangeastudy.com). The second aim is a  randomized controlled trial of early versus usual care rehabilitation consultation. Children enrolled in the early group will begin therapies within 72 hours of ICU admission; those in the usual care group will begin therapies when these services are ordered by treating physicians. Children ages 3–17 years with acute brain injury expected to be admitted to the ICU > 48 hours due to trauma, infection, mass, low oxygen, or low blood flow to the brain are eligible. Therapy interventions are individualized for the child’s clinical and developmental status as usual. The effectiveness of the intervention will be measured using the Vineland Behavior Adaptive Scale (VABS) at six months post ICU admission. 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 the timing of initiation of rehabilitation improves outcomes important to patients and families for critically ill children with acute brain injury. 

For more information contact the Project Manager, Pam Rubin, at 412-692-9922