Clinical trial NCT01622699: Implementation of a Transcutaneous Bilirubinometer
Official title: Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Jaundice
Hyperbilirubinemia
Keywords: Jaundice
Neonatal Jaundice
Hyperbilirubinemia
Transcutaneous bilirubin measurement
Transcutaneous bilirubinometry
jaundice meter
Visual assessment of bilirubin
Newborn
Lead sponsor: Princess Amalia Children's Clinic
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 430
Sex: ALL
Minimum age (years): 24
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
timeFrame: up to 1 year
Secondary outcomes:
measure: Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
timeFrame: up to 1 year
measure: Highest Measured Serum Bilirubin-value
timeFrame: up to 1 year
measure: Number of Patients Having Kernicterus
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken, Amalia Childrens Clinic
state: Overijssel
Study officials:
affiliation: Isala
name: Jolita Bekhof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.