An interventional study of Petale in Petale, Hearing Disorders and Child Development, sponsored by Ramsay Générale de Santé. Status unknown at 1 site in France. Open to participants aged 9 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-11.
Sponsored by Ramsay Générale de Santé · Not applicable, Interventional, and Prevention
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.
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.
61 studies on the registry are indexed under Hearing Disorders; 17 are open to participants now.
This study's planned enrollment of 300 is above the median of 31 across 41 interventional studies indexed under Hearing Disorders.
Browse Hearing Disorders studies →Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 2 weeks
Specificity
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
Positive Predictive Value (PPV):
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Time frame: 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.
Time frame: 2 weeks
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Ramsay Générale de Santé