Congenital Heart Disease
Conditions
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.
Interventions
None listed
Sponsors
Pediatrix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Positive Rate | 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. |
| False Positive Rate | 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. |
| True Negative Rate | 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. |
| False Negative Rate | 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. |
Countries
United States
Outcome results
None listed