Preliminary Study of Pediatric Diaphragmatic Elastography

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new method called diaphragmatic elastography to measure the stiffness of the diaphragm in children who have had a congenital diaphragmatic hernia. The goal is to compare these stiffness measurements with those from children who haven't had this condition. By understanding the stiffness of the diaphragm, doctors hope to better monitor symptoms and predict potential problems like breathing issues or reflux. This study uses a safe and painless ultrasound technique that allows doctors to collect information without needing any invasive procedures.

To participate in this study, children aged between 3 and 17 who are being treated at a specific hospital in Strasbourg may be eligible. The study includes two groups: one with a history of diaphragmatic hernia and a control group without this history. Participants will need to understand the study's goals and risks and provide consent. It’s important to note that some children may not qualify if they have had recent surgery, certain medical conditions, or if they cannot give informed consent. Overall, this trial aims to provide valuable insights into how these children are doing and to improve their care.

Gender

ALL

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