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Implementatiestudie screening op aangeboren hartafwijkingen in Nederland


- candidate number19633
- NTR NumberNTR4833
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-okt-2014
- Secondary IDsMETC P14.307 
- Public TitleImplementatiestudie screening op aangeboren hartafwijkingen in Nederland
- Scientific TitlePulse Oximetry screening Leiden Amsterdam Region
- ACRONYMPOLAR study
- hypothesisPulse oximetry screening for critical congenital heart defects in the Netherlands is intermediate sensitive, highly specific and cost-effective.
- Healt Condition(s) or Problem(s) studiedCongenital heart disease, Neonates, Hypoxia, Screening
- Inclusion criteriaInfants born in the Amsterdam-Leiden region.
- Exclusion criteriaInfants where pre and post ductal pulse oximetry is performed for at least 24 hours for monitoring.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2015
- planned closingdate1-feb-2017
- Target number of participants20000
- InterventionsPulse 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.
- Primary outcomeAccuracy of the screening for critical congenital heart defects: sensitivity, specificity, false positive rate, positive predictive value, negative predictive value.
- Secondary outcomeCost-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
- TimepointsPreparation: 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
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES I. Narayen
- CONTACT for SCIENTIFIC QUERIES I. Narayen
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Covidien (Dublin, Ireland)
- Publications
- Brief summaryTo 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.
- Main changes (audit trail)
- RECORD6-okt-2014 - 23-jan-2015


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