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临床试验/NCT03872882
NCT03872882已完成不适用

Equipment Evaluation for Newborn Hearing Screening. A Randomised Comparison of Screen Outcome Between Standard Madsen 'Accuscreen New' and Madsen 'Accuscreen New' With Fast Refer Disabled and Increased Test Time

Julie Dawson1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Julie Dawson
入组人数
100
试验地点
1
主要终点
Screen pass or screen refer

研究概览

简要总结

An evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings to see if the new settings reduce unnecessary referrals for babies from newborn hearing screening.

Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

详细描述

All newborn babies undergo hearing screening, usually within the first few days of life and some are tested with the automated auditory brainstem response test (AABR). This involves recording activity from the hearing nerve and parts of the brainstem from three small sensors placed on the baby's head and neck when a series of clicking sounds are played in to the ear.

In March 2015 we started using an 'Accuscreen New' to record the AABR, which is approved by the Newborn Hearing Screening Programme (NHSP) and used widely across the UK. However, since introducing the new equipment the 'screen refer' rate increased significantly in very young babies (less than 48 hours old) and diagnostic testing showed they had satisfactory hearing. The impact of the increased referral rate caused increased delays on diagnostic testing and also lead to unnecessarily increased parental anxiety in relation to the hearing of their new born baby.

The equipment suppliers (GN Otometrics) and the NHSP Programme centre have agreed to an evaluation and comparison of results between the 'Accuscreen New' currently in use and an 'Accuscreen New' with different settings which we believe will reduce unnecessary referrals of so many young babies to Audiology (the modified equipment will test for up to 10 minutes to see if a response is present, instead of stopping after one or two minutes).

Babies will be tested with the standard and modified equipment. Referrals for diagnostic testing will be based on the standard equipment. A comparison in referrals between the standard and modified equipment will be made.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
1 Day 至 4 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Babies requiring AABR testing through newborn hearing screening

排除标准

  • 未提供

结局指标

主要结局

Screen pass or screen refer

时间窗: within 48 hours of birth

The referral rate is the number of babies who do not pass the newborn hearing screen.

次要结局

未报告次要终点

研究者

发起方
Julie Dawson
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Julie Dawson

Research Services Manager

Norfolk and Norwich University Hospitals NHS Foundation Trust

研究点 (1)

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