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Transcutaneous Bilirubinometry in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fouzas Sotirios, University of Patras
ClinicalTrials.gov Identifier:
NCT01422655
First received: August 22, 2011
Last updated: January 22, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Neonatal Hyperbilirubinemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Accuracy of Transcutaneous Bilirubin Determinations in Neonates: The Effect of Gestational Age, Time and Site of Measurement

Resource links provided by NLM:

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Accuracy characteristics of TcB as compared to TSB [ Time Frame: Tcb vs TSB measurements at any time from birth to 120 postnatal hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 255
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 120 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Term and preterm neonates from birth to 120 postnatal hours

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01422655

Locations
Greece
Neonatal Intensive Care Unit, University Hospital of Patras
Patras, Greece, 26504
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Sotirios Fouzas, MD Neonatal Intensive Care Unit, University Hospital of Patras
Study Director: Anastasia Varvarigou, Prof Neonatal Intensive Care Unit, University Hospital of Patras
Principal Investigator: Eugenia Panagiotopoulou, MD Neonatal Intensive Care Unit, University Hospital of Patras
  More Information

No publications provided

Responsible Party: Fouzas Sotirios, Pediatrician, Neonatal Intensive Care Unit, University Hospital of Patras, University of Patras
ClinicalTrials.gov Identifier: NCT01422655     History of Changes
Other Study ID Numbers: TcB_Patr_2011
Study First Received: August 22, 2011
Last Updated: January 22, 2012
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 19, 2013