Delirium in Children Undergoing Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

Conditions
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Stem Cell Transplant Complications, Delirium

Intervention / Treatment
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* Other: Daily screening for delirium


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Stem Cell Transplant Patients<br>A consecutive cohort of children admitted to the hospital for stem cell transplantation | Other: Daily screening for delirium<br>* Each child will be screened twice daily for delirium throughout the transplant hospitalization<br>* Other names: Cornell Assessment for Pediatric Delirium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium incidence | Number of patients who develop delirium during the course of their transplant hospitalization | 1-50 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Length of transplant hospitalization will be measured in days. | 1-365 days | 
| Mortality rate | Count will include number of patients with either in-hospital or post-discharge mortality. | 1-5 years | 
| Readmission rate | Count will include number of patients who are readmitted to the hospital within 30-days of discharge. | 1-365 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, stem cell transplant, outcomes, epidemiology