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 (PETALE)

Ramsay Générale de Santé

Status: Unknown

Conditions: Petale; Hearing Disorders; Child Development

Treatments: Device: Petale

Study type: Interventional

Funder types: Other

Identifiers

NCT05117801

2019-A02005-52

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 9 months to 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

children at the general practitioner or pediatrician

Experimental group

Description:

Children between 9 months and 3 years-old coming to their doctor for any consultation

Treatment:

Device: Petale