跳至主要内容
临床试验/NCT03251638
NCT03251638Unknown不适用

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

Assiut University0 个研究点目标入组 300 人开始时间: 2018年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
主要终点
Neonatal hearing screening

研究概览

简要总结

Hearing loss is one of the most common congenital anomalies. Early Intervention at or before 6 months of age allows a child with impaired hearing to develop normal speech and language.Auditory brainstem response , otoacoustic emissions testing have all been used in newborn hearing-screening programs

详细描述

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 .

Currently, 2 types of evoked otoacoustic emissions measurements are used for newborn hearing screening: transient evoked otoacoustic emissions and distortion product otoacoustic emissions . Provided that the patient's middle ear function is normal, these measurements can be used to assess cochlear function for the 500-6000 Hz frequency range. The presence of evoked otoacoustic emissions responses indicates hearing sensitivity in the normal to near-normal range .

The Auditory brainstem response test records brainstem electrical activity in response to sounds presented to the infant via earphones. In contrast to the otoacoustic emissions test, the The Auditory brainstem response evaluates the auditory pathway from the external ear to the level of the brainstem, enabling diagnosis of auditory neuropathy, which is a less common cause of hearing impairment .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • A) Neonates of both sexes. (B) Neonates with the following risk factors according to the Joint Committee on Infant Hearing 2000 Position Statement:
  • In utero infection such as cytomegalovirus, rubella, toxoplasmosis, or herpes.
  • Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring exchange transfusion, persistent pulmonary hypertension of the newborn associated with mechanical ventilation, and conditions requiring the use of extracorporeal membrane oxygenation
  • Low birth weight (1500-1800)grams

排除标准

  • • Absence of high risk factors in the neonates.

结局指标

主要结局

Neonatal hearing screening

时间窗: 6months

number of neonates who failed to pass emissions

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

Nesma Gamal

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

Assiut University

相似试验