Child Development, Hearing Disorders, Petale
Conditions
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.
Interventions
DEVICEPetale
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.
Sponsors
European Clinical Trial Experts Network
Ramsay Générale de Santé
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 3 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
Primary ContactJean-François Oudet
Backup ContactMarie-Hélène Barba
Outcome results
None listed