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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Congenital Heart Defect

No interventions assigned to this group

Eligibility Criteria

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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

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reese H Clark, MD

Role: PRINCIPAL_INVESTIGATOR

Pediatrix

Locations

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Capital Health Regional Medical Center - Pediatrix Medical Group

Trenton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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PDX-003-11

Identifier Type: -

Identifier Source: org_study_id