NCT04937400

Delirium in Children Undergoing Stem Cell Transplantation

Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,040 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Stem Cell Transplant Complications
• Delirium

Interventions

Type	Name	Description
OTHER	Daily screening for delirium	Each child will be screened twice daily for delirium throughout the transplant hospitalization

Timeline

• Start date: 2021-07-12
• Primary completion: 2026-07-30
• Completion: 2026-07-31
• First posted: 2021-06-24
• Last updated: 2025-11-14

Locations

6 sites across 2 countries: United States, Canada