Delirium in Children Undergoing Stem Cell Transplantation
2 other identifiers
observational
1,040
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
November 14, 2025
November 1, 2025
5.1 years
June 22, 2021
November 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delirium incidence
Number of patients who develop delirium during the course of their transplant hospitalization
1-50 days
Secondary Outcomes (4)
Hospital length of stay
1-365 days
Mortality rate
1-5 years
Readmission rate
1-365 days
Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery
pre-transplant, 3 months after transplant, 12 months after transplant
Study Arms (1)
Pediatric Stem Cell Transplant Patients
A consecutive cohort of children admitted to the hospital for stem cell transplantation
Interventions
Each child will be screened twice daily for delirium throughout the transplant hospitalization
Eligibility Criteria
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.
You may qualify if:
- Age 0-21 years old
- Admitted for purpose of stem cell transplant
You may not qualify if:
- Age \>21 years old
- Admitted for reason other than stem cell transplant (example: late post-transplant complications).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of California San Francisco
San Francisco, California, 94143, United States
Dana Farber Cancer Center
Boston, Massachusetts, 02215, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
St Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Related 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.
PMID: 33968727BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chani Traube
Weill Medical College of Cornell University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2021
First Posted
June 24, 2021
Study Start
July 12, 2021
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
November 14, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.