Delirium in Children Undergoing Stem Cell Transplantation
- Conditions
- DeliriumStem Cell Transplant Complications
- Interventions
- Other: Daily screening for delirium
- Registration Number
- NCT04937400
- Lead Sponsor
- Weill Medical College of Cornell University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1041
- Age 0-21 years old
- Admitted for purpose of stem cell transplant
- Age >21 years old
- Admitted for reason other than stem cell transplant (example: late post-transplant complications).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pediatric Stem Cell Transplant Patients Daily screening for delirium A consecutive cohort of children admitted to the hospital for stem cell transplantation
- Primary Outcome Measures
Name Time Method Delirium incidence 1-50 days Number of patients who develop delirium during the course of their transplant hospitalization
- Secondary Outcome Measures
Name Time Method Hospital length of stay 1-365 days Length of transplant hospitalization will be measured in days.
Mortality rate 1-5 years Count will include number of patients with either in-hospital or post-discharge mortality.
Readmission rate 1-365 days Count will include number of patients who are readmitted to the hospital within 30-days of discharge.
Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery pre-transplant, 3 months after transplant, 12 months after transplant 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.
Trial Locations
- Locations (6)
Weill Cornell Medical College
🇺🇸New York, New York, United States
St Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Dana Farber Cancer Center
🇺🇸Boston, Massachusetts, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada