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

Congenital Heart Disease Clinical Trial

— CCHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749059
• Other study ID #: PDX-003-11
• Status: Completed
• Phase: N/A
• First received: December 11, 2012
• Last updated: December 16, 2016
• Start date: June 2012
• Est. completion date: October 2016

Study information

• Verified date: December 2016
• Source: Mednax Center for Research, Education and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6147
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Capital Health Regional Medical Center - Pediatrix Medical Group	Trenton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education and Quality

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	True Positive Rate	The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.	One year follow-up	No
Primary	False Positive Rate	The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.	One year follow-up	No
Primary	True Negative Rate	The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.	One year follow-up	No
Primary	False Negative Rate	The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.	One year follow-up	No