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NCT Number: NCT06666140

Preliminary Study of Pediatric Diaphragmatic Elastography

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.

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Key information

Conditions

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

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: Baseline

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

Secondary outcomes

  1. 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.

    Time frame: Baseline

    Bilateral measurements for each subject of the diaphragm performed in mode B, Intercostal analysis in mode B

  2. 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.

    Time frame: Baseline

    Bilateral measurements for each subject of the diaphragm made in elastography.

  3. 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.

    Time frame: Baseline

    Bilateral measurements for each subject of the diaphragm made in TM mode, Analysis in M mode (time-movement).

  4. 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)

    Time frame: Baseline

    Collection of age and the various parameters measured by ultrasound (diaphragmatic thickness and rigidity).

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

    Time frame: Baseline

    Measurement of rigidity and collection of symptoms

Other outcomes

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

    Time frame: Baseline

    Collection of the presence of a prosthesis and the various symptoms

  2. 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

    Time frame: Baseline

    Measurement of diaphragmatic mobility in a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia

  3. 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

    Time frame: Baseline

    Evaluation of the position of the pyloric (in strict axial section passing through the hepatic hilum, pylora normally visible. Estimate its position in cm (cranio caudal) in relation to the hilum if not in place) in a group of children with a diaphragmatic hernia (with or without a prosthesis) and a group of children without a hernia

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle TALON

CONTACT

[email protected]

+33388127296 ext. Professor

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: ECHODIA

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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