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POLS study


- candidate number16339
- NTR NumberNTR4365
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-feb-2014
- Secondary IDsNL45190.058.13 
- Public TitlePOLS study
- Scientific TitlePulse oximetry screening for congenital heart disease in community based midwifery care in the Netherlands Pulse Oximetry Leiden Screening Study
- ACRONYMPOLS study
- hypothesisScreening for congenital heart defects using pulse oximetry is feasible in the Netherlands
- Healt Condition(s) or Problem(s) studiedCongenital heart disease, Screening
- Inclusion criteriaTerm neonate born in Leiden region
- Exclusion criteriaMonitored with pulse oximetry
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 8-okt-2013
- planned closingdate8-okt-2014
- Target number of participants3000
- Interventionspre and post ductal oxygen saturation measurement with pulse oximeter at least one hour after birth and at day two or three (with day of birth counting as day one)
- Primary outcomePercentage of term infants born in the Leiden region in the study period that was screened for congenital heart defects with pulse oximetry
- Secondary outcomeProblems identified in the use of PO in home setting; Problems identified with referral logistics; Sensitivity and specificity of the screening; Positive and negative predictive value of the screening Percentage of false positive referrals Other pathology found with screening with PO Acceptability of mothers
- Timepointsat least one hour after birth at day one and at day two or three (day one is day of birth)
- Trial web sitewww.polsstudie.nl
- statusopen: patient inclusion
- 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 summaryThe feasbility of neonatal screening for critical congenital heart defects is assessed in the Leiden region. Pre and post ductal oxygen saturation is measured in term neonates with a pulse oximeter at least one hour after birth and at day two or three. The screening takes place at home or in the hospital. Primary endpoint will be the percentage of term neonates born in the Leiden region in the study period that is screened for critical congenital heart defects
- Main changes (audit trail)21-3-2014: trial overgezet naar website - LH
- RECORD3-feb-2014 - 21-mrt-2014


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