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

December 16, 2016 updated by: Pediatrix
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

6147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Trenton, New Jersey, United States, 08638
        • Capital Health Regional Medical Center - Pediatrix Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neonates known to have a congenital heart defect at the time of screening.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Congenital Heart Defect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
True Positive Rate
Time Frame: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.
One year follow-up
False Positive Rate
Time Frame: One year follow-up
The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
One year follow-up
True Negative Rate
Time Frame: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.
One year follow-up
False Negative Rate
Time Frame: One year follow-up
The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.
One year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pediatrix

Investigators

  • Principal Investigator: Reese H Clark, MD, Pediatrix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 12, 2012

First Posted (Estimate)

December 13, 2012

Study Record Updates

Last Update Posted (Estimate)

December 19, 2016

Last Update Submitted That Met QC Criteria

December 16, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-003-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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