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
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Positive Predictive Value (PPV):
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
children at the general practitioner or pediatrician
Children between 9 months and 3 years-old coming to their doctor for any consultation
干预措施: Petale (Device)
结局指标
主要结局
Positive Predictive Value (PPV):
时间窗: 2 weeks
Proportion of children with hearing impairment assessed by both investigator and ENT among children with hearing impairment assessed by ENT.
Sensitivity
时间窗: 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
时间窗: 2 weeks
Proportion of children without hearing impairment assessed by the investigator knowing that they were also assessed without hearing impairment by ENT.
Negative Predictive Value (NPV)
时间窗: 2 weeks
Proportion of children without hearing impairment assessed by both investigator and ENT among children without hearing impairment assessed by ENT.
次要结局
未报告次要终点