Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

NCT04056104 | Completed DMC

• 3 other identifiers: 13862435KL2TR001859-04R21HD099239-01
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AUROC of CCHD screening algorithm for any critical congenital heart defect (CCHD)

  At 30 days of life

• 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)

  At enrollment

Study Arms (1)

SpO2 and PIx Measurement

EXPERIMENTAL

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

Diagnostic Test: SpO2 and PIx Measurement

Interventions

SpO2 and PIx Measurement DIAGNOSTIC_TEST

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

SpO2 and PIx Measurement

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (6)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

University of California-Davis

Sacramento, California, 95817, United States

Location

UCSF Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

University of Utah/Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Related Publications (1)

• Siefkes H, Oliveira LC, Koppel R, Hogan W, Garg M, Manalo E, Cresalia N, Lai Z, Tancredi D, Lakshminrusimha S, Chuah CN. Machine Learning-Based Critical Congenital Heart Disease Screening Using Dual-Site Pulse Oximetry Measurements. J Am Heart Assoc. 2024 Jun 18;13(12):e033786. doi: 10.1161/JAHA.123.033786. Epub 2024 Jun 15.

  PMID: 38879455 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Oxygen Saturation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Metabolism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 14, 2019
• Study Start: October 23, 2019
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)