Implementation of a Transcutaneous Bilirubinometer
Condition: Neonatal Jaundice; Hyperbilirubinemia
MeSH terms: Jaundice, Neonatal; Jaundice; Hyperbilirubinemia
Study type: Interventional

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.
    

Intervention name(s): Transcutaneous Bilirubinometer; visual assessment of neonatal jaundice
Intervention type(s): Device; Other
Intervention description(s): 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.; 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.
Other intervention name(s): JaundiceMeter-103®, Dräger
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Jaundice; Neonatal Jaundice; Hyperbilirubinemia; Transcutaneous bilirubin measurement; Transcutaneous bilirubinometry; jaundice meter; Visual assessment of bilirubin; Newborn