Implementation of a Transcutaneous Bilirubinometer
Implementation of a Transcutaneous Bilirubinometer
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
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.
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.