Implementation of a Transcutaneous Bilirubinometer

Not Applicable

Completed

Conditions: Neonatal Jaundice
Hyperbilirubinemia

Interventions: Device: Transcutaneous Bilirubinometer
Other: visual assessment of neonatal jaundice

Registration Number: NCT01622699

Lead Sponsor: Princess Amalia Children's Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 430

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous bilirubin measurements	Transcutaneous Bilirubinometer	In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
Visual assessment of neonatal jaundice	visual assessment of neonatal jaundice	In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician

Primary Outcome Measures

Name	Time	Method
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Highest Measured Serum Bilirubin-value	up to 1 year
Number of Patients Having Kernicterus	up to 1 year	Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'	up to 1 year