To optimize the quality and cost-effectiveness of care for jaundiced neonates in the Isala Klinieken.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primairy outcome variable: the number of blood tests for bilirubin measurement
(Before the potential start of phototherapy).
Secondary outcome
Secondary outcome: Phototherapy duration in hours, Number of serum
bilirubin-values above the 'exchange transfusion limit', Highest measured serum
bilirubin-value, Cost-effectiveness (blood test, use bilirubinometer, costs
admittance), Number of patients having kernicterus.
Background summary
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.
Study objective
To optimize the quality and cost-effectiveness of care for jaundiced neonates
in the Isala Klinieken.
Study design
Randomised controlled trial
Intervention
One group receives transcutaneous measurements, the other group receives the
standard of care: visual assessment
Transcutaneous bilirubinometer: JaundiceMeter-103®, Dräger
Study burden and risks
non-invasive intervention, duration: at most 5 seconds
no risks
dr. van Heesweg 2
Zwolle 8025 AB
NL
dr. van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01622699 |
| CCMO | NL40354.075.12 |