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Набор скоро начнётся NCT07408713

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

— Наблюдательное HSCT Pediatric Cancer Pediatric Patients Late Effect

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: HSCT, Pediatric Cancer, Pediatric Patients, Late Effect. Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

The NATURE Study (Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function)

Обзор

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.

Первичные конечные точки

  • Performance on clinical neurocognitive tests [Срок оценки: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
  • Performance on clinical neurocognitive tests - Excecutive functioning [Срок оценки: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
  • Performance on clinical neurocognitive tests - Sustained attention [Срок оценки: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
  • Performance on clinical neurocognitive tests - Visuomotor functions [Срок оценки: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
  • Performance on clinical neurocognitive tests - Verbal learning [Срок оценки: T0: Within 30 days prior to HSCT T3: 1 year post HSCT]
Вторичные конечные точки (12)
  • Isometric Muscle Strength [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: T3: 1 year post HSCT]
  • Physical Activity and Sedentary Time [Срок оценки: T1: During HSCT]
  • Physical Activity and Sedentary Time [Срок оценки: T2: 6 months post HSCT T3: 1 year post HSCT]
  • Pain and morphine usage: [Срок оценки: T1: During HSCT]
  • Mucositis [Срок оценки: T1: During HSCT]

Критерии участия

Критерии включения

  • Recipient of allogeneic HSCT in the study period
  • HSCT at the pediatric ward
  • Age <18 years at referral to HSCT
  • Signed informed consent

Критерии исключения

1\) Inability of legal guardian to speak and understand Danish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT07408713 · H-25062888, The NATURE Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗