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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Congenital Heart Defect |
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| Measure | Description | Time Frame |
|---|---|---|
| True Positive Rate | 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 | 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 | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates known to have a congenital heart defect at the time of screening.
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| Name | Affiliation | Role |
|---|---|---|
| Reese H Clark, MD | Pediatrix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Health Regional Medical Center - Pediatrix Medical Group | Trenton | New Jersey | 08638 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 14, 2018 | |
| Reset | Jan 25, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 14, 2018 | Jan 25, 2019 |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |