Preliminary Study of Pediatric Diaphragmatic Elastography

Официальное название

Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia

Обзор

This diaphragmatic elastography study is a preliminary pilot study to have first values of diaphragmatic stiffness in patients with a history of diaphragmatic hernia and to estimate the difference in stiffness compared to a group of patients without a history of hernia. The hypothesis is to be able to correlate the values found with the patients' symptomatology and thus to better monitor patients by a simple, accessible, painless and reproducible diagnostic tool, to better understand their evolution and even to be able to anticipate possible difficulties (reflux, respiratory disorders, scoliosis, etc.). Ultrasound elastography is a recent and clinically recognized method that uses an ultrasound approach to determine tissue stiffness in a non-invasive way.

Вмешательства

• Другое Ultrasonic elastography
  The measurement of diaphragmatic stiffness by shear waves is performed with a high-frequency linear ultrasound probe, intercostally, during apneas lasting a few seconds. After quantitative diaphragm thickness measurements, the ultrasound probe positioning is unchanged and regions of interest are placed in the patient's diaphragm thickness as well as in the adjacent liver or spleen (baseline). A stiffness result is obtained in kPa. The elastography measurement extends the duration of the ultras

Первичные конечные точки

• To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with or without a prosthesis and a group of children without any diaphragmatic pathology. [Срок оценки: Baseline]

Вторичные конечные точки (5)

• To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. [Срок оценки: Baseline]
• To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. [Срок оценки: Baseline]
• To estimate the difference in diaphragm stiffness between a group of children with a diaphragmatic hernia with a prosthesis and a group of children with a diaphragmatic hernia without a prosthesis. [Срок оценки: Baseline]
• To evaluate the correlation between age and the different parameters measured by ultrasound (on the total population and then within the 3 groups: no hernia, hernia with plaque, hernia without plaque) [Срок оценки: Baseline]
• To estimate the association between patient stiffness and symptomatology in HDC subjects. [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Group HDC:
• Patient followed at the CCMR (centres de compétence maladies rares) HDC of the Strasbourg University Hospital
• Aged between 3 and 17 years old inclusive
• Indifferent Sex
• Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
• Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
• Subject who has been informed of the results of the preliminary medical examination

Control group:

• Subject followed in pediatric surgery
• Aged between 3 and 17 years old inclusive
• Indifferent Sex
• Subject affiliated to a social protection health insurance scheme or beneficiary of such a scheme
• Subject able to understand the objectives and risks of the research and to provide dated and signed informed consent
• Subject who has been informed of the results of the preliminary medical examination

Критерии исключения

• Group HDC:

• Refusal
• Language barrier
• Diaphragmatic surgery within the last 3 months
• Patient with a viral picture in progress at the time of examination (assessment by the investigator)
• Patient treated with muscle relaxant
• Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under safeguard of justice
• Subject under guardianship or curatorship
• Pregnant or breastfeeding woman

Control group:

• Patient without thoracic pathology
• Refusal
• Language barrier
• Diaphragmatic pathology
• Any myopathy
• History of surgery of the upper digestive tract (esophagus and/or gastric and/or duodenal)
• Patient on muscle relaxant
• Patient with a viral picture in progress at the time of examination (assessment by the investigator)
• Patient treated with muscle relaxant
• Inability to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under safeguard of justice
• Subject under guardianship or curatorship
• Pregnant or breastfeeding woman

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• Hôpitaux Universitaires de Strasbourg — Strasbourg

Идентификаторы

NCT: NCT06666140 · 9420 · 2024-A01627-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗