Screening for Critical Congenital Heart Disease in Newborns

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Recruiting N/A Interventional Study
Congenital Heart Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
0 Minutes – 21 Days
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
320 (estimated)
Sponsor
University of California, Davis · Other
Who this trial is looking for

This trial is looking for newborns under 22 days old who might have heart issues. Participants will undergo a special screening test to check for critical congenital heart disease.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am under 22 days old
  • I am a newborn suspected of having congenital heart disease
  • I am a newborn with suspected or confirmed critical congenital heart disease
  • I am an asymptomatic newborn undergoing SpO2 screening for CCHD

You may not be able to join if

  • I had an echocardiogram before joining the trial
  • I am a newborn with only a patent ductus arteriosus or atrial septal defect without other defects
  • I have had heart surgery or catheter treatment before joining the trial
  • I am currently receiving vasoactive medications other than prostaglandin therapy

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial

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.

Trial Locations
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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 newbo…
Contacts

Heather Siefkes, MD, MSCI

916-713-7697

hsiefkes@ucdavis.edu

CONTACT

Elva Horath, IMG

916-713-7697

ethorath@ucdavis.edu

CONTACT