Overview

This trial is active, not recruiting.

Condition congenital heart disease
Sponsor Mednax Center for Research, Education and Quality
Start date June 2012
End date August 2016
Trial size 6000 participants
Trial identifier NCT01749059, PDX-003-11

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
True Positive Rate
time frame: One year follow-up
False Positive Rate
time frame: One year follow-up
True Negative Rate
time frame: One year follow-up
False Negative Rate
time frame: One year follow-up

Eligibility Criteria

Male or female participants up to 30 days old.

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

Additional Information

Official title The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
Principal investigator Reese H Clark, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Mednax Center for Research, Education and Quality.