Active not recruitingOBSERVATIONAL

Delirium in Children Undergoing Stem Cell Transplantation

This important study is focusing on something called delirium, which is a temporary change in a child's thinking and behaviour, often seen in those who are very unwell. We know that adults undergoing stem cell transplants can experience delirium, but we don't know much about it in children having this treatment. Researchers want to understand how often delirium occurs in children undergoing stem cell transplants, what might put them at risk, and how it affects their recovery and thinking abilities afterwards. The main goal is to eventually find ways to prevent or reduce delirium in these children, helping them have the best possible outcomes after their transplant. This study is for children aged 21 and under who are having a stem cell transplant.

At a glance

Status

Active not recruiting

Sponsor

Weill Medical College of Cornell University

Enrolment target

1,040

Start

12 Jul 2021

Estimated completion

31 Jul 2026

Stem Cell Transplant Complications Delirium

What is this study about?

When children are very unwell and having major medical procedures like a stem cell transplant, they can sometimes experience something called delirium. Delirium is a sudden and temporary change in how a person thinks, understands things, and behaves. It’s not the same as being sleepy or confused from medication; it's a specific condition where their attention might wander, they might seem disorientated, or even have strange thoughts or see things that aren't there. We know this can happen in adults, but doctors don't yet fully understand how often it happens in children having stem cell transplants, or what causes it in younger patients.

This study is designed to answer these important questions. Researchers will carefully watch a large number of children (around 1000) during and after their stem cell transplant to see if they develop delirium. They will also look at different factors that might increase a child's risk of developing delirium, such as their age, other health conditions, or certain treatments they receive. The study will also explore how delirium might affect a child's recovery, including their thinking and memory skills in the longer term.

The ultimate aim of this research is to gain a clear picture of delirium in children undergoing stem cell transplants. By understanding who is most at risk and why, doctors hope to develop better ways to prevent delirium from happening or to treat it more effectively if it does occur. This could significantly improve the recovery and overall well-being of many children going through this challenging treatment.

Key takeaways

This study is about understanding delirium in children having stem cell transplants.
Delirium is a temporary change in thinking and behaviour during illness.
Researchers want to know how often it happens, why, and its effects on recovery.
The goal is to find ways to reduce delirium and improve children's outcomes.
It involves observing children aged 21 and under during their transplant journey.

Who may be eligible?

This study is looking for children and young people who are aged 21 or younger. To be considered for the study, they must be admitted to hospital specifically to have a stem cell transplant.

Children and young people older than 21 years old cannot take part in this study. Also, if a child is in hospital for a reason other than having a stem cell transplant – for example, if they're there for problems that might happen much later after a transplant – then they won't be able to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged 21 or younger?
Is your child coming into hospital for a stem cell transplant?
Is your child NOT admitted for problems that happened long after a transplant?
Is your child NOT older than 21 years of age?

Answer every question to see your result.

What does participation involve?

This study primarily involves observing and gathering information from medical records and standard care. Children won't receive any new medications or treatments specifically for the study. Instead, they will be screened daily for delirium using specific tools by trained staff. This screening process would be part of their routine care. Researchers will also collect information about their health, treatments, and how they recover, over time. They will also look at how delirium affects their thinking and memory skills in the future. The total duration of participation will depend on how long a child is in hospital and their follow-up care related to the transplant, but the main observations for delirium will happen during the transplant period.

Potential risks and benefits

The potential benefit of taking part in this study is contributing to important knowledge that could help many other children undergoing stem cell transplants in the future. By understanding more about delirium in this group, doctors may be able to improve care and reduce complications. There are no direct medical benefits to your child from taking part, as no new treatments are being given. The potential risks are minimal, as the study mainly involves observation and reviewing existing medical information. The daily screening might take a few extra minutes but should not cause any discomfort. You are always free to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (6)

University of California San Francisco
Verified postcode
San Francisco, United States
Dana Farber Cancer Center
Verified postcode
Boston, United States
Weill Cornell Medical College
Verified postcode
New York, United States
Children's Hospital of Philadelphia
Verified postcode
Philadelphia, United States
St Jude Children's Research Hospital
Verified postcode
Memphis, United States
Hospital for Sick Children
Verified postcode
Toronto, Canada

Common questions

What is a stem cell transplant?

A stem cell transplant is a medical procedure that replaces unhealthy blood-forming cells with healthy ones. It's often used to treat certain cancers and other diseases affecting the blood or immune system.

What is delirium?

Delirium is a sudden and temporary state of confusion. A child might have trouble paying attention, seem disoriented, or even act differently than usual. It's often caused by being very ill or having a major medical procedure.

Will my child receive extra medication?

No, your child will not receive any extra or different medications as part of this study. The study focuses on observation and understanding.

How long will my child be in the study?

The main part of the study involves observations during your child's time around their stem cell transplant. Longer-term follow-up may be collected on their thinking skills as part of their regular post-transplant care.

Will taking part affect my child's treatment?

No, your child's medical treatment will not be affected whether they take part in the study or not. They will receive the same high standard of care.