Transcutaneous Bilirubinometry in Neonates

NCT01422655 | Completed

• 1 other identifier: TcB_Patr_2011
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 120 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Term and preterm neonates from birth to 120 postnatal hours

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Neonatal Intensive Care Unit, University Hospital of Patras

Pátrai, 26504, Greece

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sotirios Fouzas, MD

  Neonatal Intensive Care Unit, University Hospital of Patras

  PRINCIPAL INVESTIGATOR

• Anastasia Varvarigou, Prof

  Neonatal Intensive Care Unit, University Hospital of Patras

  STUDY DIRECTOR

• Eugenia Panagiotopoulou, MD

  Neonatal Intensive Care Unit, University Hospital of Patras

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician, Neonatal Intensive Care Unit, University Hospital of Patras

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 24, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 24, 2012

Record last verified: 2012-01

Locations

GR (1)