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)

November 2, 2021 updated by: Ramsay Générale de Santé
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lambres-lez-Douai, France, 59552
        • Recruiting
        • Clinique Saint-Amé
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: children at the general practitioner or pediatrician
Children between 9 months and 3 years-old coming to their doctor for any consultation
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks
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.
2 weeks
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.
2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2021

Primary Completion (ACTUAL)

October 4, 2021

Study Completion (ANTICIPATED)

July 4, 2022

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (ACTUAL)

November 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 11, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02005-52

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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