Clinical Trial: Long QT Syndrome Screening in Newborns

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: ECG Device for Long QT Syndrome Screening in Newborns

Brief Summary:

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:

  1. To validate the capacity of QTScreen for LQTS screening in newborns.
  2. To determine the extent to which parents are able to use QTScreen on their babies at home.
  3. To survey end-user experience and opinions.
  4. To estimate the LQTS prevalence in California.

Detailed Summary:

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 d
Sponsor: QT Medical, Inc.

Current Primary Outcome:

  • Determine LQTS risk via QTc Measurement and family/personal history [ Time Frame: 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).
  • Determine if parents are able to use QTScreen on babies at home [ Time Frame: 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.


Original Primary Outcome:

Current Secondary Outcome:

  • Follow-up for false negatives and survey end-user experience [ Time Frame: at 1 year after LQTS screening ]
    A research assistant will conduct a follow-up of each subject when the subject turns 1 year of age. For subjects <1 year of age when the project ends, the family will be contacted at the end of the project period and when the subject turns 1 year. Parents will be inquired about: any diagnosis of LQTS, heart disease, fainting, seizures, or sudden death (SIDS) after the screening. If a subject had fainting or seizures but no subsequent cardiac evaluation, he/she will be scheduled for a repeat QTScreen. If a subject died of sudden unexplained death or SIDS, the parents will be offered ECG and genetic testing for LQTS. After the follow-up questions, parents will be surveyed on their experience with QTScreen.
  • Estimate the LQTS prevalence in California [ Time Frame: 18 to 24 months (within 6 months after the clinical trial is completed) ]
    The large sample size and use of genetic conformation in this study provides a unique opportunity to evaluate the LQTS prevalence, as well as differences in certain ethnic groups, such as Latinos and White. The number of subjects with confirmed LQTS includes true positives, identified by positive QTScreen testing followed by gene testing, and false negatives identified by telephone follow up and subsequent confirmation. Prevalence data will be reported as the proportion of subjects with confirmed LQTS (and binomial exact 95% CI).


Original Secondary Outcome:

Information By: QT Medical, Inc.

Dates:
Date Received: April 1, 2015
Date Started: June 2015
Date Completion: March 2017
Last Updated: September 26, 2016
Last Verified: September 2016