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Search / Trial NCT05637814

Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Dec 1, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Machine Learning Algorithm Pulse Oximetry

ClinConnect Summary

This clinical trial is looking at a new way to screen for a serious heart condition called critical congenital heart disease (CCHD) in newborns and young children. The study aims to use a special computer program that analyzes certain measurements from a simple test called pulse oximetry, which checks how well oxygen is being carried in the blood. The goal is to see if this new method can help identify CCHD more effectively, ensuring that affected babies receive the care they need as early as possible.

To participate in this trial, babies must be 22 days old or younger and may include those who are suspected to have congenital heart disease or are asymptomatic (showing no symptoms) while undergoing routine screening. However, certain conditions, such as having had specific heart procedures or being on certain medications, may exclude them from the trial. If eligible, participants will undergo regular monitoring and testing to help researchers assess the effectiveness of this new screening approach. This study is currently recruiting participants of all genders, and it represents an important step in improving heart health for infants and children.

Gender

ALL

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.

About University Of California, Davis

The University of California, Davis (UC Davis) is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials and studies. With a strong focus on interdisciplinary collaboration, UC Davis leverages its extensive expertise in medical research, education, and patient care to drive breakthroughs in various fields, including medicine, public health, and agriculture. The university's clinical trial programs emphasize rigorous scientific methodology and ethical standards, aiming to translate research findings into impactful treatments and improved patient outcomes. Through its state-of-the-art facilities and a dedicated team of researchers and healthcare professionals, UC Davis is at the forefront of transforming healthcare practices and addressing critical health challenges.

Locations

Davis, California, United States

Queens, New York, United States

Salt Lake City, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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