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Идёт набор NCT05501587

Measures of Respiratory Health Registry

Наблюдательное Respiratory Disease Cystic Fibrosis

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: Respiratory Disease, Cystic Fibrosis. Базовые параметры: 0 лет — 99 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
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Обзор

There are many techniques that can allow for the quantification of lung function in children; some are being used clinically and others are under development. Many of these tools are available at BC Children's Hospital. This registry study will act as a central repository for the results of traditional and novel pulmonary function tests done at BC Children's Hospital to allow for future analysis.

Подробное описание

The scope of the registry is to collect data on small airways function in healthy children, children with cystic fibrosis (CF) and children with non-CF respiratory disease using the multiple breath washout (MBW) system. These data will be stored along with demographic data, clinical data, and traditional pulmonary function testing (PFT) data. The MBW data will be collected with concurrent with clinically indicated PFT testing.

The purpose of the registry is to 1/ establish a locally collected normal range of small airways function across the paediatric age range and 2/ to collect these measurements in CF and non-CF respiratory disease.

Ultimately, the objective of this registry is to validate MBW technology as a tool that can be utilized in clinical care.

Первичные конечные точки

  • To validate new lung function testing technologies [Срок оценки: 10 years]

Критерии участия

Participants with CF

Критерии включения

-Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria: i. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT).

ii. A documented genotype with two disease-causing mutations in the CFTR gene.

\- In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Критерии исключения

  • Physical findings at the screening that would compromise the safety of the participant or the quality of the data (e.g. respiratory distress or work of breathing)
  • Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Participants with other Respiratory Disease

Критерии включения

  • Physician-diagnosed lung disease
  • Informed consent by participant, parent, or legal guardian
  • In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Критерии исключения

  • Physical findings at screening that would compromise the safety of the participant or the quality of the research data
  • Requirement of supplementary oxygen to maintain oxygen saturation above 95%

Healthy Participants

  • Inclusion criteria
  • Informed consent by participant, parent, or legal guardian
  • In the opinion of the investigator, the participant will likely have the ability to perform the lung function test of interest on the day of testing

Критерии исключения

  • Physical findings at screening that would compromise the safety of the participant or the quality of the research data
  • Evidence of lung disease

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
  • British Columbia Children's Hospital — Vancouver

Идентификаторы

NCT: NCT05501587 · H18-00812

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗