Long QT Syndrome Screening in Newborns
Status unconfirmed · Phase 2
Conditions studied: Long QT Syndrome
In brief
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.
Key facts
- Study ID
- NCT02412709
- Run by
- QT Medical, Inc.
- People needed
- 4000
- Starts
- 2015-06-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2016-09-28
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Born at ≥36 weeks of gestation.
- Birth weight 2.5-4.5 kg
You may not qualify if…
- 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.
Where it is running
- St. Francis Medical Center — Lynwood, California, United States (enrolling)
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
- Providence Little Company of Mary Medical Center-Torrance — Torrance, California, United States (enrolling)
Full record on ClinicalTrials.gov
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