NCT06666140

Preliminary Study of Pediatric Diaphragmatic Elastography

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Diaphragmatic Hernia

Interventions

Type	Name	Description
OTHER	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 ultrasound scheduled as part of patient care by only 10 minutes. The examination is painless and non-invasive.

Timeline

• Start date: 2024-11-15
• Primary completion: 2027-11-15
• Completion: 2027-11-15
• First posted: 2024-10-30
• Last updated: 2024-10-30

Locations

1 site across 1 country: France