Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04937400

Delirium in Children Undergoing Stem Cell Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stem Cell Transplant Complications Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Daily screening for delirium

Other

Each child will be screened twice daily for delirium throughout the transplant hospitalization

Other names: Cornell Assessment for Pediatric Delirium

Primary outcomes

  1. Delirium incidence

    Time frame: 1-50 days

    Number of patients who develop delirium during the course of their transplant hospitalization

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2021
Registry last updated
Nov 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.