PETALE: 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

Sponsor

Ramsay Générale de Santé (Other)

Overall Status

Recruiting

CT.gov ID

NCT05117801

Collaborator

European Clinical Trial Experts Network (Other)

300

Enrollment

Location

Arm

17.9

Anticipated Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Petale Hearing Disorders Child Development	Device: Petale	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 4, 2021

Actual Primary Completion Date :

Oct 4, 2021

Anticipated Study Completion Date :

Jul 4, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 3 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Saint-Amé	Lambres-lez-Douai		France	59552

Sponsors and Collaborators

Ramsay Générale de Santé
European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ramsay Générale de Santé

ClinicalTrials.gov Identifier:

NCT05117801

Other Study ID Numbers:

2019-A02005-52

First Posted:

Nov 11, 2021

Last Update Posted:

Nov 11, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hearing Disorders

Study Results

No Results Posted as of Nov 11, 2021