Clinical trial NCT06666140: Preliminary Study of Pediatric Diaphragmatic Elastography
Official title: Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Diaphragmatic Hernia
Keywords: congenital diaphragmatic hernia
ultrasound elastography
Chronic respiratory diseases
pulmonary hypertension
hypoplasia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: Baseline
Secondary outcomes:
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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.
timeFrame: Baseline
measure: 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)
timeFrame: Baseline
measure: To estimate the association between patient stiffness and symptomatology in HDC subjects.
timeFrame: Baseline
Other outcomes:
measure: To estimate the association between the absence of the prosthesis and the symptomatology of patients in HDC subjects
timeFrame: Baseline
measure: To estimate the difference in diaphragmatic mobility between a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia
timeFrame: Baseline
measure: To estimate the difference in pyloric position between a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia
timeFrame: Baseline
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
name: Isabelle TALON, Professor
role: PRINCIPAL_INVESTIGATOR
References: