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
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 4, 2021
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2022
CompletedNovember 11, 2021
November 1, 2021
9 months
October 28, 2021
November 2, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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
Specificity
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):
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)
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
2 weeks
Study Arms (1)
children at the general practitioner or pediatrician
EXPERIMENTALChildren between 9 months and 3 years-old coming to their doctor for any consultation
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- European Clinical Trial Experts Networkcollaborator
Study Sites (1)
Clinique Saint-Amé
Lambres-lez-Douai, 59552, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 11, 2021
Study Start
January 4, 2021
Primary Completion
October 4, 2021
Study Completion
July 4, 2022
Last Updated
November 11, 2021
Record last verified: 2021-11