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临床试验/NCT03716362
NCT03716362撤回不适用

Neonatal Hearing Screening at Neonatal Intensive Care Unit of Assiut University Hospital

Assiut University1 个研究点 分布在 1 个国家开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit

研究概览

简要总结

Hearing loss is one of the most common congenital anomalies . It has been shown to be greater than that of most other diseases and syndromes (eg, phenylketonuria, sickle cell disease) screened at birth. Data from the newborn hearing-screening programs in Rhode Island, Colorado, and Texas showed that 2-4 of every 1000 neonates have hearing loss.

Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language, alongside his or her hearing peers and can prevent severe psychosocial, educational, and language impairment.

One of the most high risk population are neonates who spend time in the newborn intensive care unit , exposed to high frequency ventilation, hyperbilirubinemia, low birth-weight, and exposed to ototoxic medications.

Auditory brainstem response , otoacoustic emissions , and automated Auditory brainstem response testing have all been used in newborn hearing-screening programs. otoacoustic emissions are fast objective, efficient, and frequency-specific measurements of peripheral auditory sensitivity are used to assess response of the outer hair cells to acoustic stimuli. To measure otoacoustic emissions, a probe assembly is placed in the ear canal, tonal or click stimuli are delivered, and the otoacoustic emissions generated by the cochlea is measured with a microphone .

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

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

入选标准

  • Neonates of both sexes.
  • Neonates with In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
  • Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion.

排除标准

  • neonates whose parent refuse to participate in the study.

结局指标

主要结局

Prevalence of hearing loss in all neonates in Neonatal Intensive Care Unit

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Lecturer

Assiut University

研究点 (1)

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