Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Diagnostic test: SpO2 and PIx Measurement

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • David Geffen School of Medicine at UCLA
    • Sacramento, California, United States, 95816
      • Sutter Institute for Medical Research
    • Sacramento, California, United States, 95817
      • University of California-Davis
    • San Francisco, California, United States, 94158
      • UCSF Benioff Children's Hospital
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah/Primary Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SpO2 and PIx Measurement; Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters	Diagnostic test: SpO2 and PIx Measurement; Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Receiver Operating Characteristics (AUROC) of critical congenital heart defect (CCHD) screening algorithm for CCHD with systemic obstruction from coarctation of the aorta or interrupted aortic arch	A CCHD screening algorithm will be created by simultaneously measuring oxygen saturation, perfusion index, and pulse oximetry waveform analysis from right upper and any lower extremity in newborns with and without CHD. Investigators will use cross-validation to test the newly developed algorithms and estimate AUROC for the specified types of heart defects. For purposes of defining primary and secondary criterion variables, the CHD will be considered present or absent at enrollment when the infant is less than 22 days of age according to the latest diagnostic assessment available for the infant (echocardiogram and/or physical examination). Because some CHDs can be diagnosed at later dates despite earlier negative diagnostic evaluations, investigators will reconfirm the presence or absence of the outcome at a minimum of 6 weeks of age for all patients except those who die or are lost to follow-up.	At enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD)	AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD). CCHD will be defined as an anatomical heart defect that requires surgical or catheter-based corrective/palliative procedure in the first 30 days after birth	At 30 days of life
AUROC of CCHD screening algorithm for critical congenital heart defect (CCHD) with any systemic obstruction	AUROC of CCHD screening algorithm for critical congenital heart defect (CCHD) with any systemic obstruction	At enrollment
AUROC of CCHD screening algorithm for any congenital heart defect (CHD)	AUROC of CCHD screening algorithm for any congenital heart defect (CHD). CHD will be defined as any anatomical heart with the exception of isolated patent ductus arteriosus and/or atrial septal defect/patent foramen ovale	At enrollment

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): December 12, 2021
• Study Completion (Actual): December 12, 2021

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: August 12, 2019
• First Posted (Actual): August 14, 2019

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: 1386243; 5KL2TR001859-04 (U.S. NIH Grant/Contract); R21HD099239-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No