Implementation of a Transcutaneous Bilirubinometer
Primary Purpose
Neonatal Jaundice, Hyperbilirubinemia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Transcutaneous Bilirubinometer
visual assessment of neonatal jaundice
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Jaundice focused on measuring Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn
Eligibility 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.
Sites / Locations
- Isala Klinieken, Amalia Childrens Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transcutaneous bilirubin measurements
Visual assessment of neonatal jaundice
Arm Description
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
Outcomes
Primary Outcome Measures
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
Secondary Outcome Measures
Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
Highest Measured Serum Bilirubin-value
Number of Patients Having Kernicterus
Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Full Information
NCT ID
NCT01622699
First Posted
June 12, 2012
Last Updated
December 14, 2019
Sponsor
Princess Amalia Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT01622699
Brief Title
Implementation of a Transcutaneous Bilirubinometer
Official Title
Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Princess Amalia Children's Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice, Hyperbilirubinemia
Keywords
Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous bilirubin measurements
Arm Type
Experimental
Arm Description
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
Arm Title
Visual assessment of neonatal jaundice
Arm Type
Active Comparator
Arm Description
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
Intervention Type
Device
Intervention Name(s)
Transcutaneous Bilirubinometer
Other Intervention Name(s)
JaundiceMeter-103®, Dräger
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
visual assessment of neonatal jaundice
Intervention Description
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 Measure Information:
Title
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
Time Frame
up to 1 year
Title
Highest Measured Serum Bilirubin-value
Time Frame
up to 1 year
Title
Number of Patients Having Kernicterus
Description
Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
8 Days
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof, MD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken, Amalia Childrens Clinic
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025AB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
15231951
Citation
American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297. Erratum In: Pediatrics. 2004 Oct;114(4):1138.
Results Reference
background
PubMed Identifier
19785881
Citation
Dijk PH, de Vries TW, de Beer JJ; Dutch Pediatric Association. [Guideline 'Prevention, diagnosis and treatment of hyperbilirubinemia in the neonate with a gestational age of 35 or more weeks']. Ned Tijdschr Geneeskd. 2009;153:A93. Dutch.
Results Reference
background
PubMed Identifier
15365826
Citation
Szabo P, Wolf M, Bucher HU, Fauchere JC, Haensse D, Arlettaz R. Detection of hyperbilirubinaemia in jaundiced full-term neonates by eye or by bilirubinometer? Eur J Pediatr. 2004 Dec;163(12):722-7. doi: 10.1007/s00431-004-1533-7.
Results Reference
background
PubMed Identifier
27940715
Citation
van den Esker-Jonker B, den Boer L, Pepping RM, Bekhof J. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016 Dec;138(6):e20162414. doi: 10.1542/peds.2016-2414. Epub 2016 Nov 4.
Results Reference
derived
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Implementation of a Transcutaneous Bilirubinometer
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