Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

543 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2021-12-12

Brief Summary

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The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.

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Detailed Description

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This study will create and test an enhanced critical congenital heart defect (CCHD) screen that combines non-invasive measurements of oxygenation and perfusion in two ways. The first will use current equipment without automated interpretation and the second will require additional software/device but will automate the interpretation. To work towards development of those two algorithms in this stage of the study, the study team will download oxygen saturation (SpO2) and perfusion index (PIx) measurements from newborns with and without congenital heart disease (CHD) and apply statistical tests to the data afterwards to identify parameters to include in the newly developed screening algorithms. The overall objective is to create an automated screening algorithm to improve acyanotic CCHD detection, preventing morbidity and mortality associated with diagnoses missed by SpO2 screening. The central hypothesis is that the addition of non-invasive perfusion measurements to SpO2 will be superior to SpO2-alone screening for detection of acyanotic CCHD. The data collected during this study will be used to develop the two algorithms and the algorithms will be compared to the standard of care using statistical tests on the data after the fact (k-fold validation). The newly developed algorithms will not be tested in-situ on patients during this study.

Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Non-invasive measurements of oxygenation and perfusion will be measured with pulse oximeters

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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SpO2 and PIx Measurement

Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters

Group Type EXPERIMENTAL

SpO2 and PIx Measurement

Intervention Type DIAGNOSTIC_TEST

Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured

Interventions

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SpO2 and PIx Measurement

Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age \< 22 days
* and either: a) asymptomatic newborn undergoing SpO2 screening for CCHD, or 2b) newborn prenatally or postnatally diagnosed/suspected with CHD.

Exclusion Criteria

* For Controls: 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 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.

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No