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

This study is currently recruiting participants.
Verified March 2014 by Pediatrix Medical Group
Sponsor:
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01749059
First received: December 11, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Pediatrix Medical Group:

Primary Outcome Measures:
  • True Positive Rate [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
    The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have CCHD.

  • False Positive Rate [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
    The numbers of subjects who have a positive pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.

  • True Negative Rate [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
    The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have normal hearts.

  • False Negative Rate [ Time Frame: One year follow-up ] [ Designated as safety issue: No ]
    The number of subjects who have a negative pulse oximetry screening test and who in follow-up evaluation are found to have heart defects.


Estimated Enrollment: 6000
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Congenital Heart Defect

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749059

Contacts
Contact: Amy Kelleher, MSHS 800-243-3839 ext 5026 amy_kelleher@pediatrix.com

Locations
United States, New Jersey
Capital Health Regional Medical Center - Pediatrix Medical Group Recruiting
Trenton, New Jersey, United States, 08638
Contact: Stephen T Moffitt, M.D.         
Principal Investigator: Stephen T Moffitt, M.D.         
Sponsors and Collaborators
Pediatrix Medical Group
Investigators
Principal Investigator: Reese H Clark, MD Pediatrix Medical Group
  More Information

No publications provided

Responsible Party: Pediatrix Medical Group
ClinicalTrials.gov Identifier: NCT01749059     History of Changes
Other Study ID Numbers: PDX-003-11
Study First Received: December 11, 2012
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 21, 2014