Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Part of paid clinical trials in Davis, California.

Sponsor
University of California, Davis
Study ID
NCT05637814
Status
Recruiting
Apply to this trial

Conditions

  • Congenital Heart Disease

Eligibility Criteria

Sex
ALL
Age
0 Minutes - 21 Days
Healthy Volunteers
Accepted

Interventions

  • SpO2/PIx Measurement and ML Algorithm — DIAGNOSTIC_TEST
    Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured and an online ML inference model will be used to classify a newborn as healthy versus CCHD as new pulse oximetry data is collected.

Study Details

The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.

Key Dates

Start date
Aug 17, 2023
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: SpO2 and PIx Measurement
    Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters and a ML CCHD screening algorithm will be assigning a prediction every minute.

Primary Outcome Measure

Area under the curve for receiver operating characteristics for critical congenital heart disease using ML inpatient algorithm. [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterDavisCalifornia95616
Heather Siefkes, MD, MSCI
[email protected]
Heather Siefkes, MD, MSCI (PRINCIPAL_INVESTIGATOR)
Cohen Children's Medical CenterQueensNew York11040
Robert Koppel, MD
[email protected]
Robert Koppel, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Health CareSalt Lake CityUtah84102
Whitnee Hogan, MD
[email protected]
Whitnee Hogan, MD (PRINCIPAL_INVESTIGATOR)

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