PetalePETALENCT05117801
Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician
A study testing Petale in people with Petale and Hearing Disorders, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children. Read more about this study
- Who is it for?
- Ages 9 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Petale, Hearing Disorders, Child Development
- What is being tested?
- Petale
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jan 2021to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Chil, girl or boy between 9 months and 3 years-old
- Child seen in consultation by a general practitioner or a pediatrician whatever the reason for consultation
- Child attached to a beneficiary of a social security scheme
- Signature of informed consent by parents.
Who cannot join
- Age greater than 3 years and less than 9 months
- Refusal of one or more parents during the consultation
- State of the child which does not allow the screening test to be carried out
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Clinique Saint-Amé
Lambres-lez-Douai, 59552
Bruno MAETZ, Dr, 06 07 87 70 26, brunomaetz@gmail.com
About this study
The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.
Read the detailed description
The research procedure is auditory stimulation using Pétale® (small equipment for testing the child's hearing) based on the "orientation reflex" ("Ewing" test): the child is seated on the companion's knees between the two enclosures and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.
- Conditions
- Petale, Hearing Disorders, Child Development
- Being tested
- Petale
- Medical subject headings
- Hearing Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PetaleDevice
The child sits on the companion's lap between the two enclosures, and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.
| Study group | Role | What they receive |
|---|---|---|
| children at the general practitioner or pediatrician | Experimental | Children between 9 months and 3 years-old coming to their doctor for any consultation Receives: Device: Petale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Proportion of children with a hearing impairment assessed by the investigator knowing that they were also assessed with a hearing impairment by ENT specialist.
Measured: 2 weeks
Specificity
Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.
Measured: 2 weeks
Positive Predictive Value (PPV):
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Measured: 2 weeks
Negative Predictive Value (NPV)
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start4 Jan 2021
- Primary completion4 Oct 2021
- Study completion4 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PetaleStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117801
- Sponsor's protocol ID
- 2019-A02005-52
- Acronym
- PETALE
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pétale® (Small Hearing Test Equipment for Children) for the Screening of Hearing Disorders in Children From 9 Months to 3 Years Old by the General Practitioner or Pediatrician
- ClinicalTrials.gov ID
- NCT05117801
- Acronym / sponsor ID
- PETALE / 2019-A02005-52
- Conditions
- Petale, Hearing Disorders, Child Development
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Jul 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
The aim of this study is to confirm the value of this new version of Pétale® ((small equipment for testing the child's hearing) in the daily practice of general practitioners or pediatricians for the screening of hearing disorders in very young children.
Detailed description
The research procedure is auditory stimulation using Pétale® (small equipment for testing the child's hearing) based on the "orientation reflex" ("Ewing" test): the child is seated on the companion's knees between the two enclosures and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children at the general practitioner or pediatrician | Experimental | Device: PetaleChildren between 9 months and 3 years-old coming to their doctor for any consultation |
Who may qualify
- Ages
- 9 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Chil, girl or boy between 9 months and 3 years-old
- Child seen in consultation by a general practitioner or a pediatrician whatever the reason for consultation
- Child attached to a beneficiary of a social security scheme
- Signature of informed consent by parents.
Key exclusion criteria (3 listed)
- Age greater than 3 years and less than 9 months
- Refusal of one or more parents during the consultation
- State of the child which does not allow the screening test to be carried out
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 |
|---|---|---|
| PetaleThe child sits on the companion's lap between the two enclosures, and the investigator observes whether or not he is attracted to a familiar calibrated noise coming from one side or the other. | Device | children at the general practitioner or pediatrician |
Primary outcome
Sensitivity
Time frame: 2 weeks
Proportion of children with a hearing impairment assessed by the investigator knowing that they were also assessed with a hearing impairment by ENT specialist.
Specificity
Time frame: 2 weeks
Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.
Positive Predictive Value (PPV):
Time frame: 2 weeks
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Negative Predictive Value (NPV)
Time frame: 2 weeks
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Petale in people with Petale and Hearing Disorders, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 2 weeks). The study lists 4 primary outcomes in all. 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 11 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.