Children undergoing stem cell transplants are at risk for delirium, a temporary change in thinking and behavior. This study will define delirium rates, risk factors, and outcomes. Our eventual goal is to reduce delirium in this population.
Delirium -- defined as an acute change in awareness and cognition that occurs in the setting of an underlying illness -- is a common complication of hematopoietic stem cell transplantation (HSCT) in adults, with associated morbidity and mortality. This has never been studied in children, where risk factors may vary substantially from adults. The objectives of this study are: to define the epidemiology of delirium, and measure its effect on outcomes. This prospective longitudinal cohort study will prospectively establish the incidence of delirium in 1000 children in the peri-transplant period, and identify modifiable risk factors that predispose to delirium development. This study will also define the effect of delirium on important clinical outcomes, including neurocognitive function. This study will be executed by a research consortium of five leading pediatric oncologic transplant centers in North America, in collaboration with the leading pediatric delirium research group in the United States. This innovative proposal will leverage the combined experience of the pediatric delirium and HSCT teams to expand urgently needed delirium research into a unique and unstudied population. By reducing delirium rates, outcomes after pediatric HSCT can be optimized.
Study Type
OBSERVATIONAL
Enrollment
1,040
Each child will be screened twice daily for delirium throughout the transplant hospitalization
University of California San Francisco
San Francisco, California, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Delirium incidence
Number of patients who develop delirium during the course of their transplant hospitalization
Time frame: 1-50 days
Hospital length of stay
Length of transplant hospitalization will be measured in days.
Time frame: 1-365 days
Mortality rate
Count will include number of patients with either in-hospital or post-discharge mortality.
Time frame: 1-5 years
Readmission rate
Count will include number of patients who are readmitted to the hospital within 30-days of discharge.
Time frame: 1-365 days
Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery
Neurocognitive functioning will be measured by the NIH Toolbox Cognition Battery, and reported as a total composite score ranging from 50-150. An average score, adjusted for age, is 100. A score lower than 100 indicates lower cognitive functioning than average; a score higher than 100 indicates higher cognitive functioning than average.
Time frame: pre-transplant, 3 months after transplant, 12 months after transplant
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St Jude Children's Research Hospital
Memphis, Tennessee, United States
Hospital for Sick Children
Toronto, Ontario, Canada