Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Sandhya Kharbanda, MD
Headshot of Sandhya Kharbanda
Sandhya Kharbanda

Description

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.

Official Title

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

Details

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.

Keywords

Stem Cell Transplant Complications, Delirium, pediatric, stem cell transplant, outcomes, epidemiology, Daily screening for delirium

Eligibility

You can join if…

Open to people ages up to 21 years

  • Age 0-21 years old
  • Admitted for purpose of stem cell transplant

You CAN'T join if...

  • Age >21 years old
  • Admitted for reason other than stem cell transplant (example: late post-transplant complications).

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • St Jude Children's Research Hospital accepting new patients
    Memphis Tennessee 38105 United States

Lead Scientist at UCSF

  • Sandhya Kharbanda, MD
    Dr. Sandhya Kharbanda is a specialist in pediatric blood disorders and stem cell transplantation, and the medical director of the pediatric blood and marrow transplant program at UCSF Benioff Children's Hospital San Francisco.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Weill Medical College of Cornell University
ID
NCT04937400
Study Type
Observational
Participants
Expecting 1000 study participants
Last Updated