Delirium in Children Undergoing Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT04937400|
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : September 14, 2022
|Condition or disease||Intervention/treatment|
|Stem Cell Transplant Complications Delirium||Other: Daily screening for delirium|
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|
|Estimated Enrollment :||1000 participants|
|Official Title:||Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes|
|Actual Study Start Date :||July 12, 2021|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||August 2026|
Pediatric Stem Cell Transplant Patients
A consecutive cohort of children admitted to the hospital for stem cell transplantation
Other: Daily screening for delirium
Each child will be screened twice daily for delirium throughout the transplant hospitalization
Other Name: Cornell Assessment for Pediatric Delirium
- Delirium incidence [ Time Frame: 1-50 days ]Number of patients who develop delirium during the course of their transplant hospitalization
- Hospital length of stay [ Time Frame: 1-365 days ]Length of transplant hospitalization will be measured in days.
- Mortality rate [ Time Frame: 1-5 years ]Count will include number of patients with either in-hospital or post-discharge mortality.
- Readmission rate [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937400
|Contact: Chani Traubefirstname.lastname@example.org|
|Contact: Keshia Smallemail@example.com|
|United States, California|
|University of California San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Sandhya Kharbanda Sandhya.Kharbanda@ucsf.edu|
|Principal Investigator: Sandhya Kharbanda, MD|
|United States, Massachusetts|
|Dana Farber Cancer Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Christine Duncan Christine_Duncan@dfci.harvard.edu|
|Principal Investigator: Christine Duncan, MD|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Chani Traube firstname.lastname@example.org|
|Principal Investigator: Chani Traube, MD|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Jason Freedman FreedmanJ@chop.edu|
|Principal Investigator: Jason Freedman, MD|
|United States, Tennessee|
|St Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Caitlin Hurley Caitlin.Hurley@STJUDE.ORG|
|Principal Investigator: Caitlin Hurley, MD|
|Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Yogi Chopra email@example.com|
|Principal Investigator: Yogi Chopra, MD|
|Principal Investigator:||Chani Traube||Weill Medical College of Cornell University|