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Implementation of a Transcutaneous Bilirubinometer

This study is not yet open for participant recruitment.
Verified December 2012 by Princess Amalia Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier:
NCT01622699
First received: June 12, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

Rationale:

Neonatal jaundice, caused by hyperbilirubinemia, is frequently seen in healthy newborns. Severe hyperbilirubinemia can cause bilirubin encephalopathy (kernicterus). 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.

Objective:

To evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates.

Study design:

Randomized controlled trial

Study population:

All jaundiced newborns beyond a gestational age of 32 weeks and younger than 8 days who are admitted at the maternity-ward or the neonatal-ward of our hospital.

Intervention:

Assessment of jaundice by use of a transcutaneous bilirubinometer.

Control:

Visual assessment of jaundice (current standard of care)

Main study parameters/endpoints:

Primary outcome variable:

The number of blood punctures for bilirubin measurement.

Secondary outcome:

Phototherapy duration in hours, amount of bilirubin-values above the exchange transfusion limit, highest measured serum bilirubin, costs (blood test, use bilirubinometer, costs admittance)

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Burden: A non-invasive transcutaneous measurement using a transcutaneous bilirubinometer (harmless light-reflection-technique). It takes at most 5 seconds to perform the measurement at the forehead or sternum.

Risk:It could be possible that a severe hyperbilirubinemia will be missed. This is a greater risk in the control group, due to the fact that visual assessment is known to be unreliable. When in doubt, the clinical team will have the authority to determine the serum bilirubin-value.


Condition Intervention
Neonatal Jaundice
Hyperbilirubinemia
 Device: Transcutaneous Bilirubinometer
Other: visual assessment of neonatal jaundice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Jaundice
U.S. FDA Resources

Further study details as provided by Princess Amalia Children's Clinic:

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

Secondary Outcome Measures:
  • Phototherapy duration in hours [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
  • Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
  • Highest measured serum bilirubin-value [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternityward.

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


Estimated Enrollment: 210
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcutaneous bilirubin measurements 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 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.

  Eligibility

Ages Eligible for Study:   up to 8 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622699

Contacts
Contact: Bernice vd Esker 0031384245050 b.t.van.den.esker@isala.nl

Locations
Netherlands
Isala Klinieken, Amalia Childrens Clinic Not yet recruiting
Zwolle, Overijssel, Netherlands, 8025AB
Contact: Bernice vd Esker, B.     0031384245050     b.t.van.den.esker@isala.nl    
Contact: Jolita Bekhof, MD     0031384245050     j.bekhof@isala.nl    
Sub-Investigator: Bernice vd Esker, B.            
Sponsors and Collaborators
Princess Amalia Children's Clinic
Investigators
Principal Investigator: Jolita Bekhof, MD Isala Klinieken
  More Information

Publications:

Responsible Party: Princess Amalia Children's Clinic
ClinicalTrials.gov Identifier: NCT01622699     History of Changes
Other Study ID Numbers: TcB AmaliaCC
Study First Received: June 12, 2012
Last Updated: December 4, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Princess Amalia Children's Clinic:
Jaundice
Neonatal Jaundice
Hyperbilirubinemia
Transcutaneous bilirubin measurement
 Transcutaneous bilirubinometry
JM-103 jaundice meter
Visual assessment of bilirubin
Newborn

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

ClinicalTrials.gov processed this record on May 23, 2013