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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01749059
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief Summary:
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 or disease
Congenital Heart Disease

Study Type : Observational
Actual Enrollment : 6147 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease
Study Start Date : June 2012
Primary Completion Date : October 2016
Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Congenital Heart Defect



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749059


Locations
United States, New Jersey
Capital Health Regional Medical Center - Pediatrix Medical Group
Trenton, New Jersey, United States, 08638
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
Principal Investigator: Reese H Clark, MD Mednax Center for Research, Education, Quality and Safety

Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT01749059     History of Changes
Other Study ID Numbers: PDX-003-11
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

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