Congenital Diaphragmatic HerniaECHODIANCT06666140
Preliminary Study of Pediatric Diaphragmatic Elastography
A study testing Ultrasonic elastography in people with Congenital Diaphragmatic Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Congenital Diaphragmatic Hernia
- What is being tested?
- Ultrasonic elastography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2024to 15 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia
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
- Being tested
- Ultrasonic elastography
- Keywords
- congenital diaphragmatic hernia, ultrasound elastography, Chronic respiratory diseases, pulmonary hypertension, hypoplasia
- Medical subject headings
- Hernias, Diaphragmatic, Congenital, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic elastographyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group HDC | Experimental | 40 children with diaphragmatic hernia with or without prosthesis (HDC) Receives: Other: Ultrasonic elastography |
| Control Group | Other | 40 children free of any diaphragmatic pathology Receives: Other: Ultrasonic elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Bilateral measurements for each subject of the diaphragm performed in mode B, Intercostal analysis in mode B
Measured: 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.
Bilateral measurements for each subject of the diaphragm made in elastography.
Measured: 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.
Bilateral measurements for each subject of the diaphragm made in TM mode, Analysis in M mode (time-movement).
Measured: 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)
Collection of age and the various parameters measured by ultrasound (diaphragmatic thickness and rigidity).
Measured: Baseline
To estimate the association between patient stiffness and symptomatology in HDC subjects.
Measurement of rigidity and collection of symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle TALON, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666140
- Sponsor's protocol ID
- 9420
- Other IDs
- 2024-A01627-40
- Acronym
- ECHODIA
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Functional Analysis of the Diaphragm and Upper Digestive Tract in Patients with Congenital Diaphragmatic Hernia
- ClinicalTrials.gov ID
- NCT06666140
- Acronym / sponsor ID
- ECHODIA / 9420
- Conditions
- Congenital Diaphragmatic Hernia
- Keywords
- congenital diaphragmatic hernia, ultrasound elastography, Chronic respiratory diseases, pulmonary hypertension, hypoplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group HDC | Experimental | Other: Ultrasonic elastography40 children with diaphragmatic hernia with or without prosthesis (HDC) |
| Control Group | Other | Other: Ultrasonic elastography40 children free of any diaphragmatic pathology |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (24 listed)
- Group HDC:
- Patient without thoracic pathology
- Refusal
- Language barrier
- Diaphragmatic pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic elastographyThe 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. | Other | Control Group, Group HDC |
Primary outcome
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).
5 secondary outcomes
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
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
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
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
To estimate the association between patient stiffness and symptomatology in HDC subjects.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle TALON, Professor principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic elastography in people with Congenital Diaphragmatic Hernia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle TALON (+33388127296 ext. Professor, isabelle.TALON@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2024.