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Long QT Syndrome Screening in Newborns

NCT02412709 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4000

Last updated 2016-09-28

No results posted yet for this study

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.

Conditions

  • Long QT Syndrome

Interventions

DEVICE

QTScreen ECG Recorder

Subjects will be randomly assigned to the: Parents Performing ECG (PPE) group or Staff Performing ECG (SPE) group. This will assess whether parents are able to use QTScreen on babies at home.

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • University of California, Irvine

    collaborator OTHER

  • QT Medical, Inc.

    lead OTHER

Principal Investigators

  • Ruey-Kang Chang, M.D., M.P.H. · QT Medical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02412709 on ClinicalTrials.gov