Implementation of a Transcutaneous Bilirubinometer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01622699
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : July 19, 2016
Information provided by (Responsible Party):
Princess Amalia Children's Clinic

Brief Summary:
Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Assessment of the degree of jaundice is usually done visually,and if necessary serum bilirubin is investigated in a blood sample. The visual assessment is subjective and can alternatively be replaced by transcutaneous measurement.The transcutaneous bilirubinometer is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. Little is known about the effect of the actual use of a bilirubinometer on the quality of care. Further evidence is needed to evaluate whether transcutaneous bilirubin measurements improve clinical outcome (use of blood tests, phototherapy and exchange transfusion), shorten length of stay and reduce costs. Therefore we aim to perform a Randomized controlled trial to evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates, a gestational age of 32 weeks. The assessment of jaundice by use of a transcutaneous bilirubinometer is compared to visual assessment of jaundice

Condition or disease Intervention/treatment
Neonatal Jaundice Hyperbilirubinemia Device: Transcutaneous Bilirubinometer Other: visual assessment of neonatal jaundice

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
Study Start Date : October 2013
Primary Completion Date : April 2016
Study Completion Date : May 2016

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Arm Intervention/treatment
Experimental: Transcutaneous bilirubin measurements
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
Device: Transcutaneous Bilirubinometer
If a baby is jaundiced, the ward-nurse will perform a transcutaneous bilirubin measurement. It takes about 5 seconds to perform the measurement at the forehead or sternum of the baby. The device is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. This is not an invasive procedure: A light-reflection is used to measure transcutaneous bilirubin.
Other Name: JaundiceMeter-103®, Dräger
Active Comparator: Visual assessment of neonatal jaundice
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
Other: visual assessment of neonatal jaundice
To detect newborns with jaundice (who will possibly meet the criteria for phototherapy) there have been international guidelines formulated by the American Academy of Pediatrics. The standard of care at the neonatal- and maternity ward of our hospital to detect those newborns is visual assessment according to these guidelines.

Primary Outcome Measures :
  1. Number of blood tests for bilirubin measurement (Before the potential start of phototherapy). [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Phototherapy duration in hours [ Time Frame: up to 1 year ]
  2. Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ]
  3. Highest measured serum bilirubin-value [ Time Frame: up to 1 year ]
  4. Cost-effectiveness [ Time Frame: up to 1 year ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternity ward.

  5. Number of patients having kernicterus [ Time Frame: up to 1 year ]
    Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.

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Ages Eligible for Study:   up to 8 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All newborns at the pediatric- and maternity-ward with visible jaundice.
  • Gestational age of 32 weeks or more.
  • Older than 24 hours.
  • Younger than 8 days.

Exclusion Criteria:

  • Neonatal jaundice within 24 hours or after 8 days
  • Hemolysis present based on maternal history (for example irregular erythrocyte antibodies)
  • Bilirubin encephalopathy
  • Newborns during/after phototherapy
  • Large congenital anomaly at forehead/sternum
  • Serum bilirubin-value is already known before admission to the pediatric ward;those newborns are to be admitted because the serum bilirubin-level has reached the phototherapy or exchange transfusion limit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01622699

Isala Klinieken, Amalia Childrens Clinic
Zwolle, Overijssel, Netherlands, 8025AB
Sponsors and Collaborators
Princess Amalia Children's Clinic
Principal Investigator: Jolita Bekhof, MD Isala

Responsible Party: Princess Amalia Children's Clinic Identifier: NCT01622699     History of Changes
Other Study ID Numbers: TcB AmaliaCC
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Princess Amalia Children's Clinic:
Neonatal Jaundice
Transcutaneous bilirubin measurement
Transcutaneous bilirubinometry
jaundice meter
Visual assessment of bilirubin

Additional relevant MeSH terms:
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hyperbilirubinemia, Neonatal
Infant, Newborn, Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs