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

Pediatrix

Status: Completed

Conditions: Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01749059

PDX-003-11

Details and patient eligibility

About

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.

Enrollment: 6,147 patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

6,147 participants in 1 patient group

Congenital Heart Defect