The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease (CCHD)
This study is currently recruiting participants.
Verified December 2012 by Pediatrix Medical Group
Sponsor:
Pediatrix Medical Group
Information provided by (Responsible Party):
Pediatrix Medical Group
ClinicalTrials.gov Identifier:
NCT01749059
First received: December 11, 2012
Last updated: December 12, 2012
Last verified: December 2012
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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:
- Documentation of informed consent and authorization.
- Full term and late preterm newborns (EGA 35-44 weeks)
- On room air
- 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
- Parents agree to follow-up contact post discharge
Exclusion Criteria:
- On supplemental oxygen
- Admitted to the Neonatal Intensive Care Unit
- Parents do not agree to follow-up
- 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: | December 12, 2012 |
| 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 May 19, 2013