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Transcutaneous bilirubin measurement: The comparison of the reliability of transcutaneous bilirubin measurement in comparison to a measurement of plasma.


- candidate number10429
- NTR NumberNTR3099
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-okt-2011
- Secondary IDs 
- Public TitleTranscutaneous bilirubin measurement: The comparison of the reliability of transcutaneous bilirubin measurement in comparison to a measurement of plasma.
- Scientific TitleTranscutaneous bilirubin measurement: Plasma versus transcutaneous.
- ACRONYM
- hypothesisBilirubin measurement in serum in more specific and sensitiver than the measurement of transcutaneous bilirubin.
- Healt Condition(s) or Problem(s) studiedJaundice, Bilirubin, Neonates
- Inclusion criteriaNeonates between 32-42 weeks gestation in which we want to determine a bilirubin.
- Exclusion criteria1. Neonates < 32 weeks of gestation;
2. Neonates with blood type antagonism;
3. Measurement of bilirubin < than 24 hours postpartum;
4. No informed consent.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-nov-2011
- planned closingdate1-jul-2011
- Target number of participants60
- InterventionsMeasurement of bilirubin from serum, followed by transcutaneous measurements.
- Primary outcomeBilirubine levels of the two transcutaneous devices en the measurement from the serum.
- Secondary outcomeComparing of the bilirubine levels from the different devices and their sensitivity en specificity.
- TimepointsTranscutaneous measurement within 30 minutes after withdrawal of bilirubin from the serum.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Judith Demmers
- CONTACT for SCIENTIFIC QUERIES Judith Demmers
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Amphia hospital
- PublicationsN/A
- Brief summaryThis trail wil look at the specificity en sensitivity of the transcutaneous measurement of bilirubin for neonates. And compare it to the specificity en sensitivity of the measurement of bilirubin form the serum.
- Main changes (audit trail)
- RECORD11-okt-2011 - 3-nov-2011


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