NCT01169740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

July 23, 2010

Last Update Submit

March 27, 2017

Conditions

Hyperbilirubinemia, NeonatalJaundice, Neonatal

Keywords

HyperbilirubinemiaNeonatalSerum bilirubinTranscutaneous bilirubinSkin color

Outcome Measures

Primary Outcomes (1)

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

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

    12 months

Secondary Outcomes (1)

  • Differences in TcB measured at the forehead or at the sternum

    12 months

Study Arms (1)

Neonatal jaundice

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

Procedure: Measurement of bilirubin in blood and skin color

Interventions

Measurement of bilirubin in blood and skin colorPROCEDURE

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

Also known as: Diagnosis of jaundice
Neonatal jaundice

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn infants admitted to normal newborn nursery

You may qualify if:

  • Newborn infant admitted to normal newborn nursery

You may not qualify if:

  • Informed consent not obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs University Hospital

Trondheim, N-7006, Norway

Location

MeSH Terms

Conditions

Hyperbilirubinemia, NeonatalJaundice, NeonatalHyperbilirubinemia

Interventions

Blood Specimen CollectionSkin Pigmentation

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesPhysical Appearance, BodyBody ConstitutionPhysical ExaminationPigmentationPhysiological PhenomenaSkin Physiological PhenomenaIntegumentary System Physiological PhenomenaBiological Phenomena

Study Officials

  • Vibeke Videm, MD, PhD

    Norwegian University of Science and Technology, Instititue director

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2013

Study Completion

October 1, 2013

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)