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Набор скоро начнётся NCT06692660

Overview: Use of Respiratory Support At Home in Children

— Наблюдательное Sleep Apnea Syndromes in Children Obesity in Children Bronchopulmonary Dysplasia (BPD) Neuromuscular Disease

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: Sleep Apnea Syndromes in Children, Obesity in Children, Bronchopulmonary Dysplasia (BPD), Neuromuscular Disease. Базовые параметры: 0 лет — 17 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
Франция
Следующий шаг
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Официальное название

An Overview of the Use of Respiratory Support At Home in Children - Patients and Families Point of View

Обзор

the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view

Подробное описание

The use of ventilatory support, including CPAP (Continuous Positive Airway Pressure), which is a mode of ventilation with continuous positive pressure, and BiPAP (Bilevel Positive Airway Pressure), which is a mode of ventilation with two levels of pressure, has seen a significant increase in indications in recent years. The indications have become more numerous and increasingly complex. Sleep-related respiratory disorders, including obstructive sleep apnea-hypopnea syndrome, central apnea syndrome, and alveolar hypoventilation, are the primary reasons for these indications. In pediatrics, numerous conditions contribute to sleep-related respiratory disorders: ENT malformations, genetic conditions, obesity, bronchopulmonary dysplasia, neuromuscular diseases, thoracic deformities, and storage diseases.

The non-use or insufficient use of ventilatory support leads to a lack of treatment for sleep-related respiratory disorders. In the absence of treatment, the consequences are neurocognitive, cardiovascular, and metabolic, resulting in high morbidity. Non-use or insufficient use is a cause of failure of ventilatory support. Neither the use nor the failure of ventilatory support is clearly defined. It is crucial to evaluate the use of ventilatory support in order to correct factors related to non-use or insufficient use and to prevent the negative consequences resulting from unaddressed sleep-related respiratory disorders. This pilot study aims to assess the use of ventilatory support at home in pediatrics through interviews with patients and their parents. We will use a questionnaire designed for the study, consisting of 10 questions regarding sleep, symptoms, quality of life, technical issues, side effects, economic barriers, and adherence, to describe their experiences with ventilatory support.

Первичные конечные точки

  • describe the perceived success of the use of the respiratory support from the parent's point of view [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
Вторичные конечные точки (6)
  • Describe the persistence of symptoms under ventilatory support according to the parent. [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
  • Describe the persistence of symptoms under ventilatory support according to the child [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
  • Describe the tolerance of ventilatory support according to the parent. [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
  • Describe the tolerance of ventilatory support according to the child. [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
  • Describe adherence to ventilatory support according to the parent. [Срок оценки: Assessment during the filling of the questionnaire at enrollment]
  • Describe adherence to ventilatory support according to the child. [Срок оценки: Assessment during the filling of the questionnaire at enrollment]

Критерии участия

Критерии включения

  • Children with respiratory support at home
  • Age 0 to 18 (not yet passed) years old

Критерии исключения

  • Palliative care
  • Invasive ventilation
  • High flow oxygen therapy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 2 центра
  • Centre Hospitalier Universitaire Grenoble Alpes — Grenoble
  • Centre Hospitalier Grenoble Alpes — La Tronche

Публикации

  • Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020. PMID 33194886
  • MacLean JE, Fauroux B. Long-term non-invasive ventilation in children: Transition from hospital to home. Paediatr Respir Rev. 2023 Sep;47:3-10. doi: 10.1016/j.prrv.2023.01.002. Epub 2023 Jan 12. PMID 36806331
  • Ramirez A, Delord V, Khirani S, Leroux K, Cassier S, Kadlub N, Aubertin G, Picard A, Fauroux B. Interfaces for long-term noninvasive positive pressure ventilation in children. Intensive Care Med. 2012 Apr;38(4):655-62. doi: 10.1007/s00134-012-2516-1. Epub 2012 Mar 6. PMID 22392032
  • McLaren AT, Bin-Hasan S, Narang I. Diagnosis, management and pathophysiology of central sleep apnea in children. Paediatr Respir Rev. 2019 Apr;30:49-57. doi: 10.1016/j.prrv.2018.07.005. Epub 2018 Jul 25. PMID 30170958
  • Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27. PMID 22926173
  • Ramirez A, Khirani S, Aloui S, Delord V, Borel JC, Pepin JL, Fauroux B. Continuous positive airway pressure and noninvasive ventilation adherence in children. Sleep Med. 2013 Dec;14(12):1290-4. doi: 10.1016/j.sleep.2013.06.020. Epub 2013 Sep 25. PMID 24157098
  • Bhattacharjee R, Benjafield AV, Armitstead J, Cistulli PA, Nunez CM, Pepin JD, Woehrle H, Yan Y, Malhotra A; medXcloud group. Adherence in children using positive airway pressure therapy: a big-data analysis. Lancet Digit Health. 2020 Feb;2(2):e94-e101. doi: 10.1016/S2589-7500(19)30214-6. Epub 2019 Dec 23. PMID 33334566
  • Amaddeo A, Frapin A, Fauroux B. Long-term non-invasive ventilation in children. Lancet Respir Med. 2016 Dec;4(12):999-1008. doi: 10.1016/S2213-2600(16)30151-5. Epub 2016 Jul 13. PMID 27423917

Идентификаторы

NCT: NCT06692660 · 2024-A01045-42

Первоисточники (государственные реестры)

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