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Transcutaneous Bilirubinometry in Neonates

NCT01422655 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2012-01-24

No results posted yet for this study

Summary

Objective: To assess the accuracy of transcutaneous bilirubin (TcB) measurements in neonates, in relation to gestational age (GA), time (postnatal hour) and site (forehead, sternum, knee) of measurements.

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.

Conditions

  • Neonatal Hyperbilirubinemia

Sponsors & Collaborators

  • University of Patras

    lead OTHER

Principal Investigators

  • Sotirios Fouzas, MD · Neonatal Intensive Care Unit, University Hospital of Patras

  • Anastasia Varvarigou, Prof · Neonatal Intensive Care Unit, University Hospital of Patras

  • Eugenia Panagiotopoulou, MD · Neonatal Intensive Care Unit, University Hospital of Patras

Eligibility

Max Age
120 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422655 on ClinicalTrials.gov