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| Name | Class |
|---|---|
| European Clinical Trial Experts Network | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| children at the general practitioner or pediatrician | Experimental | Children between 9 months and 3 years-old coming to their doctor for any consultation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Petale | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 weeks |
| Specificity | Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT. | 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. | 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. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François Oudet | Contact | 0683346567 | jf.oudet@ecten.eu | |
| Marie-Hélène Barba | Contact | mh.barba@ecten.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint-Amé | Recruiting | Lambres-lez-Douai | 59552 | France |
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| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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