Long QT Syndrome Screening in Newborns

NCT02412709 | Unknown Phase 2 DMC

• 1 other identifier: 30147-01
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 3

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

Conditions

Long QT Syndrome

Keywords

Long QT Syndrome; LQTS; genetic testing; ECG; saliva testing

Outcome Measures

Primary Outcomes (2)

• Determine LQTS risk via QTc Measurement and family/personal history

  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).

  within 1-2 business days after QTScreen recording

• Determine if parents are able to use QTScreen on babies at home

  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.

  18 to 24 months (within 6 months after the clinical trial is completed)

Secondary Outcomes (2)

• 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)

Study Arms (2)

Parent Performing ECG (PPE)

EXPERIMENTAL

Parent Performing ECG (PPE) Group--When the baby is 2 weeks old, research staff will contact interested parents to schedule a home visit. During the visit, a research assistant will provide the parents with a kit that includes the QTScreen system and instructions. The parents will perform an ECG on their child using the QTScreen and instructions. If after attempting the ECG on their own parents encounter problems, parents can ask the research assistant for assistance.

Device: QTScreen ECG Recorder

Staff Performing ECG (SPE)

ACTIVE COMPARATOR

Staff Performing ECG (SPE) Group--When the baby is 2-4 weeks of age, research staff will contact the family to schedule a home visit. The QTScreen test will be done by a research assistant.

Device: QTScreen ECG Recorder

Interventions

QTScreen ECG Recorder DEVICE

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.

Parent Performing ECG (PPE); Staff Performing ECG (SPE)

Eligibility Criteria

• Age: 2 Weeks - 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• QT Medical, Inc.: lead
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• University of California, Irvine: collaborator

Study Sites (3)

St. Francis Medical Center

Lynwood, California, 90262, United States

RECRUITING

Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

Providence Little Company of Mary Medical Center-Torrance

Torrance, California, 90503, United States

RECRUITING

Related Publications (53)

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MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruey-Kang Chang, M.D., M.P.H.

  QT Medical, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Sedano, M.S.

CONTACT

424-558-3500; ssedano@qtmedicalinc.com

Eva M Villa, M.S.

CONTACT

310-222-5383; evilla@labiomed.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 9, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (3)