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

Completed

Conditions studied: Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT01749059

Run by

Pediatrix

People needed

6147

Starts

2012-06-01

Expected to finish

2016-10-01

Last updated by the study team

2016-12-19

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documentation of informed consent and authorization.
• Full term and late preterm newborns (EGA 35-44 weeks)
• On room air
• 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
• Parents agree to follow-up contact post discharge

You may not qualify if…

• On supplemental oxygen
• Admitted to the Neonatal Intensive Care Unit
• Parents do not agree to follow-up
• Greater than 30 days of age

Where it is running

• Capital Health Regional Medical Center - Pediatrix Medical Group — Trenton, New Jersey, United States

Full record on ClinicalTrials.gov

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