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Implementation of a Transcutaneous Bilirubinometer

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ClinicalTrials.gov Identifier: NCT01622699
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Princess Amalia Children's Clinic

June 12, 2012
June 19, 2012
July 19, 2016
October 2013
April 2016   (Final data collection date for primary outcome measure)
Number of blood tests for bilirubin measurement (Before the potential start of phototherapy). [ Time Frame: up to 1 year ]
Same as current
Complete list of historical versions of study NCT01622699 on ClinicalTrials.gov Archive Site
  • Phototherapy duration in hours [ Time Frame: up to 1 year ]
  • Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ]
  • Highest measured serum bilirubin-value [ Time Frame: up to 1 year ]
  • Cost-effectiveness [ Time Frame: up to 1 year ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternity ward.
  • Number of patients having kernicterus [ Time Frame: up to 1 year ]
    Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
  • Phototherapy duration in hours [ Time Frame: up to 1 year ]
  • Number of serum bilirubin-values above the 'exchange transfusion limit' [ Time Frame: up to 1 year ]
  • Highest measured serum bilirubin-value [ Time Frame: up to 1 year ]
  • Cost-effectiveness [ Time Frame: up to 1 year ]
    Cost-effectiveness involves determination of serum bilirubin-values, use of the bilirubinometer and costs of the admission at the pediatric- or maternityward.
  • Number of patients having kernicterus [ Time Frame: up to 1 year ]
    Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Not Provided
Not Provided
 
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

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Neonatal Jaundice
  • Hyperbilirubinemia
  • 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 Name: JaundiceMeter-103®, Dräger
  • 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.
  • Experimental: Transcutaneous bilirubin measurements
    In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
    Intervention: Device: Transcutaneous Bilirubinometer
  • 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
    Intervention: Other: visual assessment of neonatal jaundice

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
210
May 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 8 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01622699
TcB AmaliaCC
No
Not Provided
Not Provided
Princess Amalia Children's Clinic
Princess Amalia Children's Clinic
Not Provided
Principal Investigator: Jolita Bekhof, MD Isala
Princess Amalia Children's Clinic
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP