Stem Cell Transplant ComplicationsNCT04937400
Delirium in Children Undergoing Stem Cell Transplantation
An observational study of Stem Cell Transplant Complications and Delirium, run by Weill Medical College of Cornell University at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Stem Cell Transplant Complications, Delirium
- What is being tested?
- Daily screening for delirium
- How many people
- 1,040 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 12 Jul 2021to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age 0-21 years old
- Admitted for purpose of stem cell transplant
Who cannot join
- Age >21 years old
- Admitted for reason other than stem cell transplant (example: late post-transplant complications).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Dana Farber Cancer Center
Boston, Massachusetts, 02215
St Jude Children's Research Hospital
Memphis, Tennessee, 38105
Weill Cornell Medical College
New York, New York, 10065
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes
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.
Read the 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
- Being tested
- Daily screening for delirium
- Keywords
- pediatric, stem cell transplant, outcomes, epidemiology
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily screening for deliriumOther
Also called Cornell Assessment for Pediatric Delirium
Each child will be screened twice daily for delirium throughout the transplant hospitalization
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Stem Cell Transplant Patients | A consecutive cohort of children admitted to the hospital for stem cell transplantation Receives: Other: Daily screening for delirium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium incidence
Number of patients who develop delirium during the course of their transplant hospitalization
Measured: 1-50 days
Secondary outcomes (4)
Hospital length of stay
Length of transplant hospitalization will be measured in days.
Measured: 1-365 days
Mortality rate
Count will include number of patients with either in-hospital or post-discharge mortality.
Measured: 1-5 years
Readmission rate
Count will include number of patients who are readmitted to the hospital within 30-days of discharge.
Measured: 1-365 days
Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery
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.
Measured: pre-transplant, 3 months after transplant, 12 months after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start12 Jul 2021
- Primary completion1 Oct 2026
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chani Traube, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937400
- Sponsor's protocol ID
- 20-08022572
- Other IDs
- R01CA244500
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared via NIH-approved repositories within 12 months after publication of primary results. The sharing of unpublished information may be subject to confidentiality issues and will need to be discussed with the appropriate institutions before any request is granted. Access will be granted to qualified researchers with a methodologically sound proposal and appropriate agreements, for academic research, meta-analyses, and other approved studies.
Publications
Traube C, Gerber LM, Mauer EA, Small K, Broglie L, Chopra YR, Duncan CN, Ebens CL, Fitzgerald JC, Freedman JL, Hudspeth MP, Hurley C, Mahadeo KM, McArthur J, Shapiro MC, Sharron MP, Wall DA, Zinter MS, Greenwald BM, Silver G, Boulad F. Delirium in Children Undergoing Hematopoietic Cell Transplantation: A Multi-Institutional Point Prevalence Study. Front Oncol. 2021 Apr 22;11:627726. doi: 10.3389/fonc.2021.627726. eCollection 2021.
PubMed 33968727
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in Children Undergoing Stem Cell Transplantation: Epidemiology and Outcomes
- ClinicalTrials.gov ID
- NCT04937400
- Acronym / sponsor ID
- 20-08022572
- Conditions
- Stem Cell Transplant Complications, Delirium
- Keywords
- pediatric, stem cell transplant, outcomes, epidemiology
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Stem Cell Transplant Patients | – | Other: Daily screening for deliriumA consecutive cohort of children admitted to the hospital for stem cell transplantation |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Age 0-21 years old
- Admitted for purpose of stem cell transplant
Key exclusion criteria (2 listed)
- Age >21 years old
- Admitted for reason other than stem cell transplant (example: late post-transplant complications).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily screening for deliriumAlso: Cornell Assessment for Pediatric DeliriumEach child will be screened twice daily for delirium throughout the transplant hospitalization | Other | Pediatric Stem Cell Transplant Patients |
Primary outcome
Delirium incidence
Time frame: 1-50 days
Number of patients who develop delirium during the course of their transplant hospitalization
4 secondary outcomes
Hospital length of stay
Time frame: 1-365 days
Mortality rate
Time frame: 1-5 years
Readmission rate
Time frame: 1-365 days
Change in neurocognitive functioning as measured by the NIH Toolbox Cognition Battery
Time frame: pre-transplant, 3 months after transplant, 12 months after transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 33968727Traube C, Gerber LM, Mauer EA, Small K, Broglie L, Chopra YR, Duncan CN, Ebens CL, Fitzgerald JC, Freedman JL, Hudspeth MP, Hurley C, Mahadeo KM, McArthur J, Shapiro MC, Sharron MP, Wall DA, Zinter MS, Greenwald BM, Silver G, Boulad F. Delirium in Children Undergoing Hematopoietic Cell Transplantation: A Multi-Institutional Point Prevalence Study. Front Oncol. 2021 Apr 22;11:627726. doi: 10.3389/fonc.2021.627726. eCollection 2021.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared via NIH-approved repositories within 12 months after publication of primary results. The sharing of unpublished information may be subject to confidentiality issues and will need to be discussed with the appropriate institutions before any request is granted. Access will be granted to qualified researchers with a methodologically sound proposal and appropriate agreements, for academic research, meta-analyses, and other approved studies.
Related trials for Stem Cell Transplant Complications
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
RecruitingEarly Phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Kidney Failure Chronic, Stem Cell Transplant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chani Traube principal investigator
Weill Medical College of Cornell University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications and Delirium, run by Weill Medical College of Cornell University at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium incidence (time frame: 1-50 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04937400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.