Implementatiestudie screening op aangeboren hartafwijkingen in Nederland
- Conditions
- Critical congenital heart defectsPotential threatening pathology causing hypoxemia in the neonate, such as persistent pulmonary hypertension, infection or sepsis.
- Registration Number
- NL-OMON25440
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20000
Inclusion Criteria
Infants born in the Amsterdam-Leiden region.
Exclusion Criteria
Infants where pre and post ductal pulse oximetry is performed for at least 24 hours for monitoring.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Accuracy of the screening for critical congenital heart defects: sensitivity, specificity, false positive rate, positive predictive value, negative predictive value.<br>
- Secondary Outcome Measures
Name Time Method Cost-effectiviness of the screening;<br /><br>Detection of other possible life threatening pathology, such as persistent pulmonary hypertension of the newborn, infection, sepsis, non-critical congenital heart defects;<br /><br>Problems identified in the use of PO in home setting;<br /><br>Problems identified with referral logistics