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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014