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
Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
1. Recipient of allogeneic HSCT in the study period
2. HSCT at the pediatric ward
3. Age \<18 years at referral to HSCT
4. Signed informed consent
Exclusion Criteria:
1\) Inability of legal guardian to speak and understand Danish
Primary outcome measure(s)
Performance on clinical neurocognitive tests — T0: Within 30 days prior to HSCT T3: 1 year post HSCT Scores on the clinical neurocognitive tests (Bayley-III: Bayley Scales of Infant and Toddler Development - Third Edition, WPPSY-IV: Wechsler Preschool and Primary Scale of Intelligence 2.6-7.7 years of age, WISC-V: Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, WAIS-IV: Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older).
Tested domains: Non-verbal reasoning, verbal reasoning, Working memory, Processing Speed Scaled scores range from 0-19, higher = better performance.
Performance on clinical neurocognitive tests - Excecutive functioning — T0: Within 30 days prior to HSCT T3: 1 year post HSCT Excecutive functioning will be tested using D-KEFS (Delis-Kaplan Executive Function System) for all participants \>8 y of age.
Performance on clinical neurocognitive tests - Sustained attention — T0: Within 30 days prior to HSCT T3: 1 year post HSCT Sustained attention will be tested using CPT-3 (Conners Continuous Performance Test, 3rd Edition) for for all participants \>8 y of age
Performance on clinical neurocognitive tests - Visuomotor functions — T0: Within 30 days prior to HSCT T3: 1 year post HSCT Visuomotor functions will be tested using Beery VMI (Beery-Buktenica Developmental Test of Visual-Motor Integration)
Performance on clinical neurocognitive tests - Verbal learning — T0: Within 30 days prior to HSCT T3: 1 year post HSCT Verbal learning will be tested using TOMAL-2 \>6 y of age
Trial sites (1)
Facility
City
Region
Status
Rigshospitalet
Copenhagen
Capital Region
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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