NCT02082431已完成不适用
Long QT & Hearing Loss Prospective Study Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss
研究概览
简要总结
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.
详细描述
The purpose of this study is to determine the true incidence of long QT (LQT) amongst a large cohort of subjects diagnosed with unilateral (right/left) or bilateral sensorineural hearing loss.
The goal of this study is to answer the following questions:
- What is the incidence of an abnormal ECG (QTc > 450 msec) in neonates greater than a week of age with either unilateral or bilateral Sensorineural hearing loss?
- What percentage of neonates greater than one week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG have an identifiable genetic mutation?
- What is the incidence of an abnormal genetic mutation consistent with long QT regardless of the ECG in neonates with bilateral sensorineural hearing loss?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All newborns who demonstrate a refer in one or both ears on a routine newborn hearing screen
- •Documentation of informed consent
- •Ability to perform an ABR (auditory brainstem response screen technology) screening test
- •No major anomalies
- •Subjects' parents willing to provide follow-up data on their child
排除标准
- •Newborns with a syndromic cause of hearing loss
- •Parents unwilling to provide follow-up data
- •Major congenital anomalies
- •Major medical problem or conditions. (i.e., hypoxic ischemic encephalopathy (HIE), persistent pulmonary hypertension neonate (PPHN), meconium aspiration, etc.)
- •Congenital cytomegalovirus (CMV)
结局指标
主要结局
The incidence of an abnormal ECG (QTc > 450) in neonates greater than a week of age with either unilateral or bilateral sensorineural hearing loss
时间窗: 6 months
ECG results to determine QTc length
次要结局
- In neonates > 1 week of age with either bilateral or unilateral sensorineural hearing loss and an abnormal ECG, percentage have an identifiable genetic mutation(One year)
研究者
研究点 (12)
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