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Completed

NCT Number: NCT01169740

Transcutaneous Measurement of Jaundice in the Newborn

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.

Completed

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Key information

Conditions

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

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Olavs University Hospital

Trondheim, N-7006, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn infant admitted to normal newborn nursery

Exclusion criteria

  • Informed consent not obtained

Treatment and study plan

Measurement of bilirubin in blood and skin color

Procedure

Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry

Other names: Diagnosis of jaundice

Primary outcomes

  1. Comparison of transcutaneous bilirubin (skin color, TcB) and bilirubin measured in a blood sample (TsB)

    Time frame: 12 months

    To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Secondary outcomes

  1. Differences in TcB measured at the forehead or at the sternum

    Time frame: 12 months

    To have statistical strength for comparison of the two tests between 1500 and 2000 patients are needed

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Registry information

Official study title

Comparison of Transcutaneous or Laboratory Measurement of Bilirubin in the Newborn

Acronym: TcBili

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2010
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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