Pulse oximetry screening for critical congenital heart disease and relevant newborn pathology in the Netherlands

Completed

• Conditions: 10007510; 10010394; congenital heart defects; 10028971

• Registration Number: NL-OMON43684
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20000

Inclusion Criteria

All infants born in the Amsterdam-Leiden region

Exclusion Criteria

pre and post ductal pulse oximetry measurements for monitoring;
Ecocardiographie performed post natally

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>In this study the primary end point will be the accuracy of PO screening for<br /><br>CCHD. The accuracy is embodied in the sensitivity, specificity, false positive<br /><br>rate, false negative rate, positive and negative predictive value.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cost-effectiveness<br /><br>Problems identified in the use of PO in home setting<br /><br>Problems identified with referral logistics<br /><br>Other pathology detected with screening with PO</p><br>