Transcutaneous Measurement of Jaundice in the Newborn

NCT ID: NCT01169740

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Hyperbilirubinemia, Neonatal Jaundice, Neonatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neonatal jaundice

Infants born between July 1st 2010 and July 31st 2010 and admitted to normal newborn nursery

Measurement of bilirubin in blood and skin color

Intervention Type PROCEDURE

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

Interventions

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Measurement of bilirubin in blood and skin color

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

Intervention Type PROCEDURE

Other Intervention Names

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Diagnosis of jaundice

Eligibility Criteria

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Inclusion Criteria

* Newborn infant admitted to normal newborn nursery

Exclusion Criteria

* Informed consent not obtained
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vibeke Videm, MD, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology, Instititue director

Locations

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St. Olavs University Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Bilirubin 2010/413

Identifier Type: -

Identifier Source: org_study_id

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