Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Congenital Heart Disease Clinical Trial

Official title:

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637814
• Other study ID #: 1933258
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: University of California, Davis
• Contact: Heather Siefkes, MD, MSCI
• Phone: 916-713-7697
• Email: hsiefkes[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Minutes to 21 Days

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Davis	California
United States	Cohen Children's Medical Center	Queens	New York
United States	University of Utah Health Care	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of repeated inpatient ML measurements	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
Other	Feasibility: Number of minutes needed to obtain simultaneous artifact free hand and foot measurements such that all pulse oximetry features can be included.	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
Other	Feasibility: Number of outpatient pulse oximetry measurements obtained	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
Primary	Area under the curve for receiver operating characteristics for critical congenital heart disease using ML inpatient algorithm.	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	Sensitivity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours)	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
Secondary	Specificity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours)	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
Secondary	Area under the curve for receiver operating characteristics for critical congenital heart disease using dynamic ML algorithm	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	Sensitivity for critical congenital heart disease using dynamic ML algorithm	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
Secondary	Specificity for critical congenital heart disease using dynamic ML model	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
Secondary	Sensitivity for critical coarctation of the aorta using dynamic ML algorithm	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