Delirium in Children Undergoing Stem Cell Transplantation
NCT ID: NCT04937400
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1040 participants
OBSERVATIONAL
2021-07-12
2026-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric Stem Cell Transplant Patients
A consecutive cohort of children admitted to the hospital for stem cell transplantation
Daily screening for delirium
Each child will be screened twice daily for delirium throughout the transplant hospitalization
Interventions
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Daily screening for delirium
Each child will be screened twice daily for delirium throughout the transplant hospitalization
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Admitted for purpose of stem cell transplant
Exclusion Criteria
* Admitted for reason other than stem cell transplant (example: late post-transplant complications).
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Chani Traube
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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University of California San Francisco
San Francisco, California, United States
Dana Farber Cancer Center
Boston, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital
Memphis, Tennessee, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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20-08022572
Identifier Type: -
Identifier Source: org_study_id