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
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Jaundice Hyperbilirubinemia||Device: Transcutaneous Bilirubinometer Other: visual assessment of neonatal jaundice||Not Applicable|
Hide Detailed Description
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.
To evaluate the cost-effectiveness of implementing the use of a transcutaneous bilirubinometer in jaundiced neonates.
Randomized controlled trial
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.
Assessment of jaundice by use of a transcutaneous bilirubinometer.
Visual assessment of jaundice (current standard of care)
Main study parameters/endpoints:
Primary outcome variable:
The number of blood punctures for bilirubin measurement.
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 (Clinical Trial)|
|Actual Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
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 Name: 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.
- Number of blood tests for bilirubin measurement (Before the potential start of phototherapy). [ Time Frame: up to 1 year ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622699
|Isala Klinieken, Amalia Childrens Clinic|
|Zwolle, Overijssel, Netherlands, 8025AB|
|Principal Investigator:||Jolita Bekhof, MD||Isala|