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
NCT ID: NCT05117801
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2021-01-04
2022-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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children at the general practitioner or pediatrician
Children between 9 months and 3 years-old coming to their doctor for any consultation
Petale
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.
Interventions
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Petale
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Refusal of one or more parents during the consultation
* State of the child which does not allow the screening test to be carried out
9 Months
3 Years
ALL
Yes
Sponsors
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European Clinical Trial Experts Network
OTHER
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Clinique Saint-Amé
Lambres-lez-Douai, , France
Countries
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Central Contacts
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Facility Contacts
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Bruno MAETZ, Dr
Role: primary
Other Identifiers
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2019-A02005-52
Identifier Type: -
Identifier Source: org_study_id