Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

University of California (UC) Davis

Status: Completed

Conditions: Congenital Heart Disease

Treatments: Diagnostic Test: SpO2/PIx Measurement and ML Algorithm

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05637814

1933258

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: Under 21 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

SpO2 and PIx Measurement

Experimental group

Description:

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.

Treatment:

Diagnostic Test: SpO2/PIx Measurement and ML Algorithm