Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorRigshospitalet, Denmark

About this trial

Hematopoietic stem cell transplantation (HSCT) is a potentially life-saving treatment for children with relapsed or resistant leukemia and other life-threatening hematological and hereditary disorders. In Denmark, around 25 children undergo allogeneic HSCT every year, of these approximately 85-90% survive into adulthood.

The goal of this observational study is to learn about neurocognitive outcomes in children undergoing (HSCT) and to understand which clinical, physical, and environmental factors may affect neurocognitive development during the first year after transplant. The main questions it aims to answer are:

How does neurocognitive function change from before HSCT to one year after transplantation in pediatric patients?

Which clinical, physical, and environmental factors are linked to better or worse neurocognitive outcomes?

Participants will:

Complete neurocognitive tests before HSCT and at 1-year follow-up, covering intelligence, memory, attention, executive function, processing speed, and motor skills.

Undergo physical tests before HSCT, at hospital discharge, at 6-months follow-up, and at 1-year follow-up, including muscle strength, mobility, endurance, balance, and cardiopulmonary fitness (only at 1-year follow-up).

Wear activity trackers to measure physical activity and sedentary time during hospitalization at 6 months and 1-year post-HSCT.

Complete questionnaires about sleep, pain, quality of life, fatigue, family background, and exposure to outdoor and green spaces.

Have medical records reviewed for treatment-related side effects, immune recovery, inflammation, and pain management.

This study will help understand how neurocognitive function develops after HSCT in children and which factors (clinical, physical, or environmental) may support better recovery and well-being.

Eligibility criteria

Qualifiers

Recipient of allogeneic HSCT in the study period

HSCT at the pediatric ward

Age <18 years at referral to HSCT

Signed informed consent

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

100 Participants
are grouped into 1 trial group

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Jascha Fonden

Collaborator

The Dagmar Marshall Foundation

Collaborator

Gangsted Foundation

Collaborator