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Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes
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.
Age
0 - 21 years
Sex
ALL
Healthy Volunteers
No
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
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Start Date
July 12, 2021
Primary Completion Date
July 30, 2026
Completion Date
July 31, 2026
Last Updated
November 14, 2025
1,040
ACTUAL participants
Daily screening for delirium
OTHER
Lead Sponsor
Weill Medical College of Cornell University
Collaborators
NCT07357389
NCT05837039
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03394365