Pulse oximetry screening for critical congenital heart disease and relevant newborn pathology in the Netherlands

Pulse oximetry screening for critical congenital heart disease and relevant newborn pathology in the Netherlands - Pulse Oximetry screening Leiden-Amsterdam Region study POLAR study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43684

Enrollment

20000

Registered

2015-01-08

Start date

2015-07-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital heart defects

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: All infants born in the Amsterdam-Leiden region

Exclusion criteria

Exclusion criteria: pre and post ductal pulse oximetry measurements for monitoring; Ecocardiographie performed post natally

Design outcomes

Primary

Measure	Time frame
In this study the primary end point will be the accuracy of PO screening for CCHD. The accuracy is embodied in the sensitivity, specificity, false positive rate, false negative rate, positive and negative predictive value.	—

Secondary

Measure	Time frame
Cost-effectiveness Problems identified in the use of PO in home setting Problems identified with referral logistics Other pathology detected with screening with PO	—

Countries

Netherlands

Outcome results