No registrations found.
ID
Source
Brief title
Health condition
Critical congenital heart defects
Potential threatening pathology causing hypoxemia in the neonate, such as persistent pulmonary hypertension, infection or sepsis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy of the screening for critical congenital heart defects: sensitivity, specificity, false positive rate, positive predictive value, negative predictive value.
Secondary outcome
Cost-effectiviness of the screening;
Detection of other possible life threatening pathology, such as persistent pulmonary hypertension of the newborn, infection, sepsis, non-critical congenital heart defects;
Problems identified in the use of PO in home setting;
Problems identified with referral logistics
Background summary
To assess the accuracy and cost-effectiveness of pulse oximetry screening for critical congenital heart defects in the Dutch perinatal care system, we perform an implementation study in the Leiden-Amsterdam region.
Study objective
Pulse oximetry screening for critical congenital heart defects in the Netherlands is intermediate sensitive, highly specific and cost-effective.
Study design
Preparation: 01-12-2014 - 01-05-2015
Starting phase: 01-05-2015 - 01-08-2015
Inclusion: 01-08-2015 - 01-02-2017
Analysis: 01-02-2017 - 01-12-2017
Intervention
Pulse oximetry reading at least one hour after birth at right hand and either foot.
Pulse oximetry reading at day two or three at right hand and either foot.
I. Narayen
Leiden
The Netherlands
63183
i.c.narayen@lumc.nl
I. Narayen
Leiden
The Netherlands
63183
i.c.narayen@lumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4681 |
| NTR-old | NTR4833 |
| Other | : METC P14.307 |