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Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

NCT05637814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Congenital Heart Disease

Interventions

DIAGNOSTIC_TEST

SpO2/PIx Measurement and ML Algorithm

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Minutes
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2024-08-02
Completion
2024-08-02

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 NCT05637814 on ClinicalTrials.gov