Delirium in Children Undergoing Stem Cell Transplantation

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Delirium; Stem Cell Transplant Complications
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1040

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Hospital for Sick Children
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Center
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St Jude Children's Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects will include all patients admitted to the five participating pediatric stem cell transplant sites for the purpose of HSCT during the study period. Enrollment goal is 1000 subjects overall, and 240 subjects for neurocognitive testing. Subjects will be seriously ill. Every patient admitted for HSCT will be eligible for inclusion, unless they are >21 years old. Subjects will be enrolled regardless of gender, race, or ethnicity. No subgroups will be excluded, as delirium likely affects children of all ages and developmental trajectories, with no predilection based on gender, race, or ethnicity.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Chani Traube, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pediatric; outcomes; epidemiology; stem cell transplant
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Delirium
• Other Study ID Numbers: 20-08022572; R01CA244500 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data will be shared via NIH-approved repositories within 12 months after publication of primary results. The sharing of unpublished information may be subject to confidentiality issues and will need to be discussed with the appropriate institutions before any request is granted. Access will be granted to qualified researchers with a methodologically sound proposal and appropriate agreements, for academic research, meta-analyses, and other approved studies.
• IPD Sharing Time Frame: De-identified IPD will be available no later than 12 months after publication of the primary results and for at least 5 years thereafter.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers with a methodologically sound proposal. Researchers must agree to a data use agreement, and requests will be reviewed by the study team and the Data Coordinating Center.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No