Clinical trial · Observational
Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function
The NATURE Study (Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HSCT | — | UNRESOLVED | — |
| Late Effect | — | UNRESOLVED | — |
| Neurocognitive Dysfunction | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric Patients | — | UNRESOLVED | — |
| Physical Capacity | — | UNRESOLVED | — |
| Physical Function | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Pediaric HSCT patients
- description
- Any pediatric HSCT patient in Denmark who meets the inclusion criteria from 2026 to 2031
Primary outcomes (5)
- measure
- Performance on clinical neurocognitive tests
- timeFrame
- T0: Within 30 days prior to HSCT T3: 1 year post HSCT
- description
- 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.
- measure
- Performance on clinical neurocognitive tests - Excecutive functioning
- timeFrame
- T0: Within 30 days prior to HSCT T3: 1 year post HSCT
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 0 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available