Transcutaneous Measurement of Jaundice in the Newborn

Completed

• Conditions: Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Interventions: Procedure: Measurement of bilirubin in blood and skin color

• Registration Number: NCT01169740
• Lead Sponsor: Norwegian University of Science and Technology

Brief Summary

Prospective comparison of measurement of bilirubin in jaundiced newborns by a transcutaneous device (bilirubinometer) and laboratory analysis of blood samples.

We hypothesise that correlation of the two measurements depend on bilirubin level, gestational age as well as postnatal age.

Detailed Description

Whenever a blood sample is drawn for measurement of bilirubin in a newborn, a transcutaneous measurement of skin yellow color will be made. Such measurements will also be included in all infants when a CRP-test (blood sample for C-reactive protein) has been ordered, as well as in connection with the routine blood sampling for metabolic screening. Only infants where parents have given written consent for their infant will be included in the study.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Primary Completion: 2013-04
• Study Completion: 2013-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Newborn infant admitted to normal newborn nursery

Exclusion Criteria

• Informed consent not obtained

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neonatal jaundice	Measurement of bilirubin in blood and skin color	Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery

Primary Outcome Measures

Name	Time	Method
Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)	12 months	To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Secondary Outcome Measures

Name	Time	Method
Differences in TcB measured at the forehead or at the sternum	12 months	To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Trial Locations

Locations (1)

St. Olavs University Hospital; 🇳🇴 Trondheim, Norway