COMPLETED

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Conditions

Congenital Heart Disease Machine Learning Algorithm Pulse Oximetry

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Quick Facts

Study Start:2023-08-17

Study Completion:2024-08-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05637814

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.

Ages Eligible for Study:0 Minutes to 21 Days

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Locations (Sites)

UC Davis Medical Center

Davis, California, 95616

United States

Cohen Children's Medical Center

Queens, New York, 11040

United States

University of Utah Health Care

Salt Lake City, Utah, 84102

United States

Collaborators and Investigators

Sponsor: University of California, Davis

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 Registration Dates

Study Start Date2023-08-17

Study Completion Date2024-08-02

Study Record Updates

Study Start Date2023-08-17

Study Completion Date2024-08-02

Terms related to this study

Keywords Provided by Researchers

Machine Learning Algorithm
Pulse Oximetry

Additional Relevant MeSH Terms

Congenital Heart Disease