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



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:7/30/2016
Start Date:June 2012
End Date:December 2016

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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.


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
We found this trial at
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Trenton, NJ
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