Implementation of a Transcutaneous Bilirubinometer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial

Conditions
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Neonatal Jaundice, Hyperbilirubinemia

Intervention / Treatment
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* Device: Transcutaneous Bilirubinometer
* Other: visual assessment of neonatal jaundice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 8 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcutaneous bilirubin measurements<br>In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer | Device: Transcutaneous Bilirubinometer<br>* 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.<br>* Other names: JaundiceMeter-103®, Dräger;|
| Active Comparator: Visual assessment of neonatal jaundice<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit' |  | up to 1 year | 
| Highest Measured Serum Bilirubin-value |  | up to 1 year | 
| 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. | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn