ECG Device for Long QT Syndrome Screening in Newborns
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 4,000
- 试验地点
- 6
- 主要终点
- Determine if parents are able to use QTScreen on babies at home
研究概览
简要总结
The purpose of this project is to test a new, very compact, 12-lead ECG device as a way to detect long QT syndrome (LQTS) in infants. The device -- called QTScreen -- was developed in Phase I of this project.
In Phase II, the goals are to test the capacity of the device for LQTS screening in newborns and to obtain prevalence data on LQTS in California.
The 4 main objectives are:
- To validate the capacity of QTScreen for LQTS screening in newborns.
- To determine the extent to which parents are able to use QTScreen on their babies at home.
- To survey end-user experience and opinions.
- To estimate the LQTS prevalence in California.
详细描述
Long QT syndrome (LQTS) is a genetic disorder characterized by a prolonged QT interval on the ECG and occurrence of syncope, ventricular arrhythmias, and sudden death. LQTS is a major cause of sudden death in infants, children, and young adults. Treatment by β-blockers and/or placement of an implantable cardioverter defibrillator (ICD) are effective in preventing sudden death, if the diagnosis of LQTS is made early.
The efficacy of ECG screening of newborns for LQTS has been demonstrated in Italy. Furthermore, within the national healthcare system in Italy, universal ECG screening in newborns (<30 days old) is cost-effective. The U.S. debate for universal LQTS screening started in the mid-2000's. In a 2007survey completed by North American pediatric cardiologists, 27% favored optional ECG screening of newborns, whereas 11% supported mandatory screening (363 responses, 35% response rate). There may be stronger support for universal screening, now that more data are available.
Obtaining a good standard 12-lead EKG on a neonate in the clinic is difficult and time consuming. If an ECG device for newborn screening were readily available, reliable, easy to use, and cost-effective, then universal screening of all 4 million newborns in the U.S. each year would identify 2,000 infants with LQTS who are at risk for sudden death, assuming the prevalence is the same as in Italy. Perhaps more than 300 deaths per year from SIDS could be prevented, as well as many more sudden deaths in children, adolescents, and young adults.
During Phase I of this project, a new device was developed to meet this clinical need (called QTScreen). In Phase II, the aim is to test the capacity of QTScreen for LQTS screening in newborns and the feasibility of home screening by parents in an ethnically diverse population of Northern and Southern California. The results of this clinical trial may validate the device as a screening tool for LQTS, and also provide important scientific data for supporting newborn screening for LQTS in the U.S.
The 4 main objectives are:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 4 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born at ≥36 weeks of gestation.
- •Birth weight 2.5-4.5 kg
排除标准
- •Babies that have been born with a heart disease.
- •Babies who have a skin condition, allergies, or chest deformities making ECG on the chest difficult or impossible.
结局指标
主要结局
Determine if parents are able to use QTScreen on babies at home
时间窗: 18 to 24 months (within 6 months after the clinical trial is completed)
Participants in the PPE group will be provided with the QTScreen recording device along with instructions for conducting an ECG on their baby. While conducting the ECG, a research assistant will access the parents' ability in properly conducting the ECG via a questionnaire.
Determine LQTS risk via QTc Measurement and family/personal history
时间窗: within 1-2 business days after QTScreen recording
A standard 12-lead ECG will be printed from the QTScreen recording. Investigators will manually measure a corrected QT interval (QTc) from lead II, and examine any clinical ECG abnormalities. Subjects with a positive history, or subjects with a median QTc ≥450 ms on the first QTScreen will be categorized as Intermediate Risk and undergo a repeat QTScreen in 2-4 weeks (before 2 months of age).
次要结局
- Follow-up for false negatives and survey end-user experience(at 1 year after LQTS screening)
- Estimate the LQTS prevalence in California(18 to 24 months (within 6 months after the clinical trial is completed))
研究者
Ruey-Kang Chang
Chief Executive Officer
QT Medical, Inc.