Delirium in Children Undergoing Stem Cell Transplantation

Delirium Clinical Trial

Official title:

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937400
• Other study ID #: 20-08022572
• Secondary ID: R01CA244500
• Status: Recruiting
• Start date: July 12, 2021
• Est. completion date: August 2026

Study information

• Verified date: August 2023
• Source: Weill Medical College of Cornell University
• Contact: Chani Traube
• Phone: 2127463030
• Email: chr9008[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

• Age 0-21 years old

• Admitted for purpose of stem cell transplant

Exclusion Criteria:

• Age >21 years old

• Admitted for reason other than stem cell transplant (example: late post-transplant complications).

Related Conditions & MeSH terms

• Delirium
• Stem Cell Transplant Complications

Intervention

Other:
• Daily screening for delirium
Each child will be screened twice daily for delirium throughout the transplant hospitalization

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Dana Farber Cancer Center	Boston	Massachusetts
United States	St Jude Children's Research Hospital	Memphis	Tennessee
United States	Weill Cornell Medical College	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Traube C, Gerber LM, Mauer EA, Small K, Broglie L, Chopra YR, Duncan CN, Ebens CL, Fitzgerald JC, Freedman JL, Hudspeth MP, Hurley C, Mahadeo KM, McArthur J, Shapiro MC, Sharron MP, Wall DA, Zinter MS, Greenwald BM, Silver G, Boulad F. Delirium in Children Undergoing Hematopoietic Cell Transplantation: A Multi-Institutional Point Prevalence Study. Front Oncol. 2021 Apr 22;11:627726. doi: 10.3389/fonc.2021.627726. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium incidence	Number of patients who develop delirium during the course of their transplant hospitalization	1-50 days
Secondary	Hospital length of stay	Length of transplant hospitalization will be measured in days.	1-365 days
Secondary	Mortality rate	Count will include number of patients with either in-hospital or post-discharge mortality.	1-5 years
Secondary	Readmission rate	Count will include number of patients who are readmitted to the hospital within 30-days of discharge.	1-365 days
Secondary	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.	pre-transplant, 3 months after transplant, 12 months after transplant