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Идёт набор NCT07121660

Post-operative Changes Study

— Наблюдательное Post-operative Functional Decline Severe Neurological Impairment

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: Post-operative Functional Decline, Severe Neurological Impairment. Базовые параметры: 5 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
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Post-operative Changes in Children With Severe Neurological Impairment

Обзор

The goal of this observational pilot study is to evaluate the feasibility and acceptability of the protocol to explore the functional post-operative trajectory in a developmentally and neurologically impaired pediatric population. The main objectives of the study are: * Objective 1: To evaluate the feasibility and acceptability of the study protocol for children and families living with severe neurological impairment (SNI). To evaluate feasibility the investigators will assess consent rate, protocol delivery and outcome completion. To evaluate acceptability, the investigators will conduct end-of-study interviews with caregivers to assess outcomes related to the ease and utility of participating in the study, including the methods of data collection. * Objective 2: To explore patterns of recovery in children with SNI during the peri-operative period. To do this, the investigators will be be assessing function in children with SNI, quality of life in children with SNI and their families, and the profile of inflammatory biomarkers during the perioperative period. The investigators will then compare the inflammatory profile of these children with SNI against a group of neurotypical children also undergoing surgery. To assess function and quality of life of the child with SNI, the investigators will be using the Caregivers Priorities and Child Health Index of Life with Disabilities (CPCHILD) Questionnaire. Parents/caregivers will also be asked to answer two supplemental questions to provide further insight into 1) other areas of function that were not described by CPCHILD and 2) the quality of life of the caregivers. To collect information on the peri-operative inflammatory profile of the child with SNI and the control participants, the investigators will collect blood samples at different peri-operative time points.

Первичные конечные точки

  • To evaluate the feasibility of the study protocol for children and their families living with severe neurological impairment. [Срок оценки: From enrollment to the end-of-study interview approximately 6 months after surgery.]
  • To evaluate the acceptability of the study protocol for children and their families living with severe neurological impairment. [Срок оценки: From enrollment to the end-of-study interview approximately 6 months after surgery.]
Вторичные конечные точки (2)
  • Assess the function in children with SNI, including exploring patterns in specific domains of gain/loss, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period. [Срок оценки: From enrollment to 6 months following surgery.]
  • Assessing the quality of life in children with SNI and their families, to explore patterns of recovery in children with severe neurological impairment (SNI) during the peri-operative period. [Срок оценки: From enrollment to 6 months following surgery.]

Критерии участия

Inclusion Criteria for Study Participants

  • Children with severe neurological impairment (SNI), including Gross Motor Function Classification System (GMFCS) levels II, III, IV and V and Communication Function Classification System (CFCS) levels II, III, IV and V, and;
  • undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as >90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
  • between 5 and 18 years at the time of their surgical procedure

Exclusion Criteria for Study Participants:

  • GMFCS level = I and CFCS level = I
  • Non-English-speaking Parents/Caregivers

Inclusion Criteria for Control Group Participants:

  • Neurotypically developing children (GMFCS I and CFCS I) and;
  • undergoing major orthopaedic surgical management of musculoskeletal pathology (spine or hip; major defined as >90 minute procedure with skin-to-skin contact) at the BC Children's Hospital and;
  • Between 5 and 18 years of age at the time of their surgical procedure

Exclusion Criteria for Control Group Participants:

1\) Non-English-speaking parents/caregivers

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • BC Children's Hospital Research Institute — Vancouver

Идентификаторы

NCT: NCT07121660 · H24-01880

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗