Implementation of a Transcutaneous Bilirubinometer

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

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

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia; Neonatal Jaundice
• Intervention / Treatment: Device: Transcutaneous Bilirubinometer; Other: visual assessment of neonatal 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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025AB
      • Isala Klinieken, Amalia Childrens Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Princess Amalia Children's Clinic
• Investigators: Principal Investigator: Jolita Bekhof, MD, Isala

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 12, 2012
• First Submitted That Met QC Criteria: June 14, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Newborn; Jaundice; Hyperbilirubinemia; Neonatal Jaundice; Transcutaneous bilirubin measurement; Transcutaneous bilirubinometry; jaundice meter; Visual assessment of bilirubin
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia, Neonatal; Jaundice; Hyperbilirubinemia; Jaundice, Neonatal
• Other Study ID Numbers: TcB AmaliaCC