Preliminary Study of Pediatric Diaphragmatic Elastography

Not Applicable

Not yet recruiting

• Conditions: Congenital Diaphragmatic Hernia

• Registration Number: NCT06666140
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11-15
• Primary Completion: 2027-11-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	Baseline	Diaphragmatic rigidity in ultrasound elastographic analysis: measurement of diaphragm stiffness in shear wave elastography, in apnea (measurement in kPa).

Secondary Outcome Measures

Name	Time	Method
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.	Baseline	Bilateral measurements for each subject of the diaphragm made in TM mode, Analysis in M mode (time-movement).
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)	Baseline	Collection of age and the various parameters measured by ultrasound (diaphragmatic thickness and rigidity).
To estimate the association between patient stiffness and symptomatology in HDC subjects.	Baseline	Measurement of rigidity and collection of symptoms

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France