Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

July 11, 2025 updated by: University of California, Davis
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will externally validate an algorithm that combines non-invasive oxygenation and perfusion measurements as a screening tool for CCHD. In a previous study, the investigators created an algorithm that combines non-invasive measurements of oxygenation and perfusion over at least two measurements using machine learning (ML) techniques. The prior model was created and tested using internal validation (k-fold validation). Thus, the investigators will test the model on an external sample of patients to test generalizability of the model. Additionally, the team will trial a repeated measurement for any "failure" of the screen to assess impact on the false positive rate. Study team will also use repeated pulse oximetry measurements (up to 4 total and including measurements after 48 hours of age, which may be done outpatient) to create a new algorithm that incorporates new data over time. The central hypothesis is that the addition of non-invasive perfusion measurements will be superior to SpO2-alone screening for CCHD detection and a model that incorporates repeated measurements will enhance detection of CCHD while preserving the specificity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • UC Davis Medical Center
    • New York
      • Queens, New York, United States, 11040
        • Cohen Children's Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • University of Utah Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 3 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age < 22 days
  • Fetuses suspected to have congenital heart disease
  • Newborns with suspected/confirmed critical congenital heart disease
  • Asymptomatic newborn undergoing SpO2 screening for CCHD

Exclusion Criteria:

  • Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD"
  • For Newborns with confirmed/suspected congenital heart disease (CHD): a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Receiver operating characteristics reflect a combination of sensitivity and specificity of a test. The investigators will identify the true positive and true negative rates for CCHD by confirming health status to a minimum of 2 months of age. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sensitivity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours)
Time Frame: Through study completion, an average of 4 years
The investigators will identify the true positive rate for CCHD by confirming health status to a minimum of 2 months of age. CCHD will be defined based on echocardiogram or parent report if echocardiogram not present. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years
Specificity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours)
Time Frame: Through study completion, an average of 4 years
The investigators will identify the true negative rate by confirming health status to a minimum of 2 months of age. CCHD will be defined based on echocardiogram or parent report if echocardiogram not present. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years
Area under the curve for receiver operating characteristics for critical congenital heart disease using dynamic ML algorithm
Time Frame: Through study completion, an average of 4 years
Receiver operating characteristics reflect a combination of sensitivity and specificity of a test. The investigators will identify the true positive and true negative rates for CCHD by confirming health status to a minimum of 2 months of age. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years
Sensitivity for critical congenital heart disease using dynamic ML algorithm
Time Frame: Through study completion, an average of 4 years
The investigators will identify the true positive rate for CCHD by confirming health status to a minimum of 2 months of age. CCHD will be defined based on echocardiogram or parent report if echocardiogram not present. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years
Specificity for critical congenital heart disease using dynamic ML model
Time Frame: Through study completion, an average of 4 years
The investigators will identify the true negative rate by confirming health status to a minimum of 2 months of age. CCHD will be defined based on echocardiogram or parent report if echocardiogram not present. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years
Sensitivity for critical coarctation of the aorta using dynamic ML algorithm
Time Frame: Through study completion, an average of 4 years
Critical coarctation of the aorta is the most commonly missed CCHD. The investigators will identify the true positive rate by confirming health status to a minimum of 2 months of age. The investigators will also utilize birth defect and death registries for missing infants.
Through study completion, an average of 4 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of repeated inpatient ML measurements
Time Frame: Through study completion, an average of 4 years
If a newborn has an initial "fail" during the inpatient ML screening algorithm, then 1 repeated measurement will occur within 3 hours after waiting at least 30 minutes. If the next repeated measurement is a "fail" then the final classification assigned will be a "fail." If the repeat measurement is a "pass" the final classification will be a "pass." To gauge impact on nursing time for repeated measurements, The investigators will quantify how often these repeated measurements occur.
Through study completion, an average of 4 years
Feasibility: Number of minutes needed to obtain simultaneous artifact free hand and foot measurements such that all pulse oximetry features can be included.
Time Frame: Through study completion, an average of 4 years
In order to incorporate the radiofemoral delay component of the pulse oximetry features, the hand and foot waveforms need to be artifact free simultaneously. The pulse oximetry device will give a result every minute to give the investigators an idea on how long it may take to reach simultaneously artifact free waveforms.
Through study completion, an average of 4 years
Feasibility: Number of outpatient pulse oximetry measurements obtained
Time Frame: Through study completion, an average of 4 years
Pulse oximetry measurements are not currently conducted in the outpatient setting. Thus, the investigators will assess feasibility for future trials based on how many outpatient measurements are obtained versus missed in the study protocol.
Through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1933258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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