Transcutaneous Bilirubinometry in Neonates

Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422655
• Other study ID #: TcB_Patr_2011
• Status: Completed
• Phase: N/A
• First received: August 22, 2011
• Last updated: January 22, 2012
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Hours

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Neonatal Hyperbilirubinemia

Locations

Country	Name	City	State
Greece	Neonatal Intensive Care Unit, University Hospital of Patras	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy characteristics of TcB as compared to TSB	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.	Tcb vs TSB measurements at any time from birth to 120 postnatal hours	No