Clinical trial NCT01422655: Transcutaneous Bilirubinometry in Neonates
Official title: Accuracy of Transcutaneous Bilirubin Determinations in Neonates: The Effect of Gestational Age, Time and Site of Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Hyperbilirubinemia
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2011-08-24
Enrollment: 255
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Term and preterm neonates from birth to 120 postnatal hours

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Born at the University Hospital of Patras
2. GA \>32 weeks
3. Parental consent to participate

Exclusion Criteria:

1. Under phototherapy
2. Congenital infections
3. Chromosomal abnormalities
4. Congenital abnormalities
5. Hepatic dysfunction

Primary outcomes:
measure: Accuracy characteristics of TcB as compared to TSB
timeFrame: Tcb vs TSB measurements at any time from birth to 120 postnatal hours
Secondary outcomes:
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Neonatal Intensive Care Unit, University Hospital of Patras
Study officials:
affiliation: Neonatal Intensive Care Unit, University Hospital of Patras
name: Sotirios Fouzas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neonatal Intensive Care Unit, University Hospital of Patras
name: Anastasia Varvarigou, Prof
role: STUDY_DIRECTOR
affiliation: Neonatal Intensive Care Unit, University Hospital of Patras
name: Eugenia Panagiotopoulou, MD
role: PRINCIPAL_INVESTIGATOR
References: