Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SpO2/PIx Measurement and ML Algorithm.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease. Basic parameters: 0 Minutes — 21 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
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.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
- 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]
- 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]
- Sensitivity for critical congenital heart disease using dynamic ML algorithm [Time frame: 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]
- Sensitivity for critical coarctation of the aorta using dynamic ML algorithm [Time frame: Through study completion, an average of 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- UC Davis Medical Center — Davis
- Cohen Children's Medical Center — Queens
- University of Utah Health Care — Salt Lake City
Identifiers
NCT: NCT05637814 · 1933258