The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT01749059
• Lead Sponsor: Pediatrix

Brief Summary

The purpose of this study is to evaluate the impact of implementing a universal pulse oximeter screening as a way to detect critical congenital heart disease in otherwise well-appearing newborns.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-12
• Study First Posted: 2012-12-13
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6147

Inclusion Criteria

1. Documentation of informed consent and authorization.
2. Full term and late preterm newborns (EGA 35-44 weeks)
3. On room air
4. Neonates known to have a congenital heart defect at the time of screening, e.g., antenatal diagnosis or diagnosis within the first 24 hours after birth
5. Parents agree to follow-up contact post discharge

Exclusion Criteria

1. On supplemental oxygen
2. Admitted to the Neonatal Intensive Care Unit
3. Parents do not agree to follow-up
4. Greater than 30 days of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
True Positive Rate	One year follow-up	The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.
False Positive Rate	One year follow-up	The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
False Negative Rate	One year follow-up	The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.
True Negative Rate	One year follow-up	The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.

Trial Locations

Locations (1)

Capital Health Regional Medical Center - Pediatrix Medical Group; 🇺🇸 Trenton, New Jersey, United States