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Delirium in Children Undergoing Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04937400
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : September 14, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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
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.

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Study Type : Observational
Estimated 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 : July 12, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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 Name: Cornell Assessment for Pediatric Delirium




Primary Outcome Measures :
  1. Delirium incidence [ Time Frame: 1-50 days ]
    Number of patients who develop delirium during the course of their transplant hospitalization


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 1-365 days ]
    Length of transplant hospitalization will be measured in days.

  2. Mortality rate [ Time Frame: 1-5 years ]
    Count will include number of patients with either in-hospital or post-discharge mortality.

  3. Readmission rate [ Time Frame: 1-365 days ]
    Count will include number of patients who are readmitted to the hospital within 30-days of discharge.

  4. Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery [ Time Frame: 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.



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04937400


Contacts
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Contact: Chani Traube 2127463030 chr9008@med.cornell.edu
Contact: Keshia Small kes4002@med.cornell.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Sandhya Kharbanda       Sandhya.Kharbanda@ucsf.edu   
Principal Investigator: Sandhya Kharbanda, MD         
United States, Massachusetts
Dana Farber Cancer Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christine Duncan       Christine_Duncan@dfci.harvard.edu   
Principal Investigator: Christine Duncan, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Contact: Chani Traube       chr9008@med.cornell.edu   
Principal Investigator: Chani Traube, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jason Freedman       FreedmanJ@chop.edu   
Principal Investigator: Jason Freedman, MD         
United States, Tennessee
St Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Caitlin Hurley       Caitlin.Hurley@STJUDE.ORG   
Principal Investigator: Caitlin Hurley, MD         
Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Yogi Chopra       yogi.chopra@sickkids.ca   
Principal Investigator: Yogi Chopra, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Chani Traube Weill Medical College of Cornell University
Publications:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04937400    
Other Study ID Numbers: 20-08022572
R01CA244500 ( U.S. NIH Grant/Contract )
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

All the participating researchers have made a commitment to publish, in a timely manner, all the relevant scientific information that they will derive during this project. Unpublished information could be made available to interested parties via a request to the Principal Investigator, in writing, to the address below, or by email.

Chani Traube, MD Professor of Pediatrics Joan & Sanford I Weill Medical College of Cornell University 1300 York Avenue New York, N.Y. 10065-4805 Phone: 212-746-3056 Email: chr9008@med.cornell.edu

The sharing of unpublished information may be subject to confidentiality issues relating to our collaborations with other scientists in academic or corporate laboratories, and will need to be discussed with the appropriate institutions before any request is granted, wholly or in part.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
pediatric
stem cell transplant
outcomes
epidemiology
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders