Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HSCT, Pediatric Cancer, Pediatric Patients, Late Effect. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The NATURE Study (Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function)
Overview
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.
Primary outcome measures
- Performance on clinical neurocognitive tests [Time frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
- Performance on clinical neurocognitive tests - Excecutive functioning [Time frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
- Performance on clinical neurocognitive tests - Sustained attention [Time frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
- Performance on clinical neurocognitive tests - Visuomotor functions [Time frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
- Performance on clinical neurocognitive tests - Verbal learning [Time frame: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
Secondary outcome measures (12)
- Isometric Muscle Strength [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Handgrip strength [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Muscle performance: Sit-to-stand 30 sec. [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Muscle performance: Sit-to-stand 60 sec. [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Muscle performance: Timed-up-and-go [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Sensory Interaction in Balance [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Gross motor skills <5 years of age [Time frame: T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT]
- Cardiorespiratory fitness [Time frame: T3: 1 year post HSCT]
- Physical Activity and Sedentary Time [Time frame: T1: During HSCT]
- Physical Activity and Sedentary Time [Time frame: T2: 6 months post HSCT T3: 1 year post HSCT]
- Pain and morphine usage: [Time frame: T1: During HSCT]
- Mucositis [Time frame: T1: During HSCT]
Eligibility criteria
Inclusion criteria
- Recipient of allogeneic HSCT in the study period
- HSCT at the pediatric ward
- Age <18 years at referral to HSCT
- Signed informed consent
Exclusion criteria
1\) Inability of legal guardian to speak and understand Danish
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07408713 · H-25062888, The NATURE Study