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

Not Applicable

• Conditions: Petale; Hearing Disorders; Child Development
• Interventions: Device: Petale

• Registration Number: NCT05117801
• Lead Sponsor: Ramsay Générale de Santé

Brief 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.

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 Timeline

• Study Start: 2021-01-04
• Primary Completion: 2021-10-04
• Study First Submitted: 2021-10-28
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-02
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-11
• Last Update Posted: 2021-11-11
• Study Completion: 2022-07-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
children at the general practitioner or pediatrician	Petale	Children between 9 months and 3 years-old coming to their doctor for any consultation

Primary Outcome Measures

Name	Time	Method
Positive Predictive Value (PPV):	2 weeks	Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Sensitivity	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	2 weeks	Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.
Negative Predictive Value (NPV)	2 weeks	Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.

Trial Locations

Locations (1)

Clinique Saint-Amé; 🇫🇷 Lambres-lez-Douai, France