N/A
N=430
Implementation of a Transcutaneous Bilirubinometer
Neonatal Jaundice · Hyperbilirubinemia
Bottom Line
View on ClinicalTrials.gov: NCT01622699 ↗Enrolled (actual)
430
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). — 0; 1 blood tests for bilirubin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous Bilirubinometer (Device); visual assessment of neonatal jaundice (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Princess Amalia Children's Clinic
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). |
0; 1 | — |
| SECONDARY Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit' |
3; 1 | — |
| SECONDARY Highest Measured Serum Bilirubin-value |
210; 217 | — |
| SECONDARY Number of Patients Having Kernicterus |
0; 0 | — |
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
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.
Data sourced from ClinicalTrials.gov (NCT01622699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.