Delirium in Children Undergoing Stem Cell Transplantation

Weill Cornell Medicine (WCM)

Status: Active, not recruiting

Conditions: Delirium; Stem Cell Transplant Complications

Treatments: Other: Daily screening for delirium

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04937400

20-08022572

R01CA244500 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,040 patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,040 participants in 1 patient group

Pediatric Stem Cell Transplant Patients

Description:

A consecutive cohort of children admitted to the hospital for stem cell transplantation

Treatment:

Other: Daily screening for delirium