Back to resultsEvaluation 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)
Primary Purpose
Petale, Hearing Disorders, Child Development
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Petale
Sponsored by
About this trial
This is an interventional prevention trial for Petale
Eligibility Criteria
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
Sites / Locations
- Clinique Saint-AméRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children at the general practitioner or pediatrician
Arm Description
Children between 9 months and 3 years-old coming to their doctor for any consultation
Outcomes
Primary Outcome Measures
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.
Specificity
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):
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Negative Predictive Value (NPV)
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
Secondary Outcome Measures
Full Information
NCT ID
NCT05117801
First Posted
October 28, 2021
Last Updated
November 2, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05117801
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 4, 2021 (Actual)
Study Completion Date
July 4, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Petale, Hearing Disorders, Child Development
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children at the general practitioner or pediatrician
Arm Type
Experimental
Arm Description
Children between 9 months and 3 years-old coming to their doctor for any consultation
Intervention Type
Device
Intervention Name(s)
Petale
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity
Description
Proportion of children with a hearing impairment assessed by the investigator knowing that they were also assessed with a hearing impairment by ENT specialist.
Time Frame
2 weeks
Title
Specificity
Description
Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.
Time Frame
2 weeks
Title
Positive Predictive Value (PPV):
Description
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Time Frame
2 weeks
Title
Negative Predictive Value (NPV)
Description
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Clinique Saint-Amé
City
Lambres-lez-Douai
ZIP/Postal Code
59552
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno MAETZ, Dr
Phone
06 07 87 70 26
Email
brunomaetz@gmail.com
12. IPD Sharing Statement
Learn more about this trial
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
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