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Machine Learning Algorithm

Pulse Oximetry Screening for Congenital Heart Defects

N/A
Recruiting
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age < 22 days
Newborns with suspected/confirmed critical congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 4 years
Awards & highlights

Study Summary

This trial tests an algorithm to detect heart defects in newborns using a pulse oximeter.

Who is the study for?
This trial is for asymptomatic newborns under 22 days old being screened for critical congenital heart disease (CCHD), including those suspected of having CCHD or with a prenatal suspicion of heart defects. Newborns who've had certain cardiac interventions, are on specific medications, or have had an echocardiogram prior to enrollment are excluded.Check my eligibility
What is being tested?
The study tests a machine learning algorithm that uses pulse oximetry data to screen for CCHD in infants. It aims to validate the effectiveness of combining oxygen saturation and perfusion index measurements from standard screenings with this new technology.See study design
What are the potential side effects?
Since the intervention involves non-invasive monitoring with pulse oximetry and data analysis through an algorithm, there are no direct side effects associated with traditional medical treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am less than 22 days old.
Select...
My newborn is suspected or confirmed to have a serious heart condition.
Select...
My unborn baby is suspected to have a heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curve for receiver operating characteristics for critical congenital heart disease using ML inpatient algorithm.
Secondary outcome measures
Area under the curve for receiver operating characteristics for critical congenital heart disease using dynamic ML algorithm
Sensitivity for critical coarctation of the aorta using dynamic ML algorithm
Sensitivity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours)
+3 more
Other outcome measures
Feasibility: Number of minutes needed to obtain simultaneous artifact free hand and foot measurements such that all pulse oximetry features can be included.
Feasibility: Number of outpatient pulse oximetry measurements obtained
Frequency of repeated inpatient ML measurements

Trial Design

1Treatment groups
Experimental Treatment
Group I: SpO2 and PIx MeasurementExperimental Treatment1 Intervention
Non-invasive measurements of oxygenation (SpO2) and perfusion (PIx) will be measured with pulse oximeters and a ML CCHD screening algorithm will be assigning a prediction every minute.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,610 Total Patients Enrolled
University of California, DavisLead Sponsor
911 Previous Clinical Trials
4,709,279 Total Patients Enrolled

Media Library

Congenital Heart Disease Clinical Trial 2023: ML Algorithm Highlights & Side Effects. Trial Name: NCT05637814 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any prerequisites for joining this medical experiment?

"This clinical trial is admitting 240 neonates aged from 0 minutes to 21 days that hold a diagnosis of congenital heart disease (CHD). Eligibility criteria include suspected/confirmed critical CHD, age below 22 days, and fetuses with probable CCHD. Furthermore, asymptomatic newborns going through pulse oximetry screening for CHD can also be considered."

Answered by AI

Are any new participants being onboarded for this research project?

"Contrary to expectation, clinicaltrials.gov has indicated that this medical trial is not actively recruiting patients at the current time; it was first posted on February 1st 2023 and last updated in December 2022. However, there are 342 other studies with open enrolment presently available for interested participants."

Answered by AI

Are there age restrictions in place for this trial?

"This research study is welcoming participants who are under 21 days old and older than 0 minutes."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
Heather Siefkes 2023. "Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05637814.
~160 spots leftby Jun 2027
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