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

Sponsor
Rigshospitalet, Denmark
Study ID
NCT07408713
Status
Not Yet Recruiting

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Conditions

  • HSCT
  • Late Effect
  • Neurocognitive Dysfunction
  • Pediatric Cancer
  • Pediatric Patients
  • Physical Capacity
  • Physical Function
  • Toxicity

Eligibility Criteria

Sex
ALL
Age
0 Years - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Feb 13, 2026
Start date
Feb 15, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Pediaric HSCT patients
    Any pediatric HSCT patient in Denmark who meets the inclusion criteria from 2026 to 2031

Primary Outcome Measure

Performance on clinical neurocognitive tests [ Time Frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT ]

Central Contacts

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