Delirium in Children Undergoing Stem Cell Transplantation

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04937400

Collaborator

National Cancer Institute (NCI) (NIH)

1,000

Enrollment

Locations

60.6

Anticipated Duration (Months)

166.7

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications Delirium	Other: Daily screening for delirium

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

Actual Study Start Date :

Jul 12, 2021

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Cornell Assessment for Pediatric Delirium

Arm

Intervention/Treatment

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 Names:

Cornell Assessment for Pediatric Delirium

Outcome Measures

Primary Outcome Measures

Delirium incidence [1-50 days]
Number of patients who develop delirium during the course of their transplant hospitalization

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143
2	Dana Farber Cancer Center	Boston	Massachusetts	United States	02215
3	Weill Cornell Medical College	New York	New York	United States	10065
4	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
5	St Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
6	Hospital for Sick Children	Toronto	Ontario	Canada