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

Child Development Clinical Trial

— PETALE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05117801
• Other study ID #: 2019-A02005-52
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: July 4, 2022

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 4, 2022
• Est. primary completion date: October 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Hearing Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Clinique Saint-Amé	Lambres-lez-Douai

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	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
Primary	Specificity	Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.	2 weeks
Primary	Positive Predictive Value (PPV):	Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.	2 weeks
Primary	Negative Predictive Value (NPV)	Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.	2 weeks