The NATURE Study (Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Performance on clinical neurocognitive tests
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recipient of allogeneic HSCT in the study period
- •HSCT at the pediatric ward
- •Age <18 years at referral to HSCT
- •Signed informed consent
排除标准
- •1) Inability of legal guardian to speak and understand Danish
研究组 & 干预措施
Pediaric HSCT patients
Any pediatric HSCT patient in Denmark who meets the inclusion criteria from 2026 to 2031
结局指标
主要结局
Performance on clinical neurocognitive tests
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: T0: Within 30 days prior to HSCT T3: 1 year post HSCT
Verbal learning will be tested using TOMAL-2 \>6 y of age
次要结局
- Isometric Muscle Strength(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(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.(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.(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(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(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(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(T3: 1 year post HSCT)
- Physical Activity and Sedentary Time(T1: During HSCT)
- Physical Activity and Sedentary Time(T2: 6 months post HSCT T3: 1 year post HSCT)
- Pain and morphine usage:(T1: During HSCT)
- Mucositis(T1: During HSCT)
- Level of inflammation and immunity(T1: During HSCT)
- Inclusion of Nature in Self(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Nature Connectedness Index (NCI)(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Experiences with and perceptions of nature(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Pediatric Quality of Life Inventory (PedsQL™) 4.0 Generic Core Scales - Child and Parent Report(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Pediatric Quality of Life Inventory (PedsQL™) Multidimensional Fatigue Scale - Child and Parent Report(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Cognitive functioning measured by the PROMIS® Cognitive Function Short Form 8a - Self-Report(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Physical activity measured by the PROMIS® Physical Activity Short Form 4a - Self-Report(T0: Within 30 days prior to HSCT T3: 1 year post HSCT)
- Patient and parental distress(T1: During HSCT)
研究者
Hilde Hylland Uhlving
MD, PhD
Rigshospitalet, Denmark