Preliminary Study of Pediatric Diaphragmatic Elastography

NCT06666140 | Not Yet Recruiting

• 2 other identifiers: 94202024-A01627-40
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Diaphragmatic Hernia

Keywords

congenital diaphragmatic hernia; ultrasound elastography; Chronic respiratory diseases; pulmonary hypertension; hypoplasia

Outcome Measures

Primary Outcomes (1)

• 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.

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

  Baseline

Secondary Outcomes (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.

  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.

  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.

  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)

  Baseline

• To estimate the association between patient stiffness and symptomatology in HDC subjects.

  Baseline

Other Outcomes (3)

• To estimate the association between the absence of the prosthesis and the symptomatology of patients in HDC subjects

  Baseline

• 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

  Baseline

• 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

  Baseline

Study Arms (2)

Group HDC

EXPERIMENTAL

40 children with diaphragmatic hernia with or without prosthesis (HDC)

Other: Ultrasonic elastography

Control Group

OTHER

40 children free of any diaphragmatic pathology

Other: Ultrasonic elastography

Interventions

Ultrasonic elastography OTHER

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.

Control Group; Group HDC

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Isabelle TALON, Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle TALON

CONTACT

+33388127296; isabelle.TALON@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: October 30, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)