Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2011-08-31
2012-01-31
Brief Summary
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Hypothesis: Using (or combining) different sites for TcB determination might improve the accuracy of TcB in relation to the time of measurement and the GA of the neonate.
Methods: The study will include neonates \>32 weeks' gestation cared for in the well-baby nursery and NICU of the University Hospital of Patras, from September to December 2011. Data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding, and extension of jaundice, will be collected.
TcB measurements will be performed using the BiliCheck bilirubinometer (according to the standard protocol) at 3 different sites: forehead, sternum and knee. Total serum bilirubin (TSB) values will be obtained using the heel stick technique, and measurements will be performed by a direct spectrophotometric device (Unistat bilirubinometer, Richert, Depew, NY). The accuracy of the device has been validated previously. TSB measurements will be performed within 5 minutes of the TcB measurements.
At each occasion TcB measurements (3), the corresponding TSB value, the time of measurement (postnatal hours), and the actual weight will be noted.
Statistics: The agreement between TcB and TSB values will be assessed using the Bland-Altman % method. The independent and joint effects of GA and time of measurement on bias will be evaluated by multivariate regression analysis.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. GA \>32 weeks
3. Parental consent to participate
Exclusion Criteria
2. Congenital infections
3. Chromosomal abnormalities
4. Congenital abnormalities
5. Hepatic dysfunction
120 Hours
ALL
No
Sponsors
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University of Patras
OTHER
Responsible Party
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Fouzas Sotirios
Pediatrician, Neonatal Intensive Care Unit, University Hospital of Patras
Principal Investigators
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Sotirios Fouzas, MD
Role: PRINCIPAL_INVESTIGATOR
Neonatal Intensive Care Unit, University Hospital of Patras
Anastasia Varvarigou, Prof
Role: STUDY_DIRECTOR
Neonatal Intensive Care Unit, University Hospital of Patras
Eugenia Panagiotopoulou, MD
Role: PRINCIPAL_INVESTIGATOR
Neonatal Intensive Care Unit, University Hospital of Patras
Locations
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Neonatal Intensive Care Unit, University Hospital of Patras
Pátrai, , Greece
Countries
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Other Identifiers
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TcB_Patr_2011
Identifier Type: -
Identifier Source: org_study_id
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