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OpenTrials
Completed

NCT Number: NCT01422655

Transcutaneous Bilirubinometry in Neonates

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.

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Key information

Age range

Up to 120 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Neonatal Intensive Care Unit, University Hospital of Patras

Pátrai, 26504, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born at the University Hospital of Patras
  • GA >32 weeks
  • Parental consent to participate

Exclusion criteria

  • Under phototherapy
  • Congenital infections
  • Chromosomal abnormalities
  • Congenital abnormalities
  • Hepatic dysfunction

Treatment and study plan

Primary outcomes

  1. Accuracy characteristics of TcB as compared to TSB

    Time frame: Tcb vs TSB measurements at any time from birth to 120 postnatal hours

    TcB measurements performed at 3 different sites (forehead, sternum, knee)will be compared with the corresponding TSB value. The agreement between TcB and TSB values will be assessed using the Bland-Altman % method. The effect of gestational age and time of measurement (postnatal hour)on TcB bias will be explored by multivariate regression analysis.

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

Accuracy of Transcutaneous Bilirubin Determinations in Neonates: The Effect of Gestational Age, Time and Site of Measurement

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 24, 2011
Registry last updated
Jan 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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