Hyperbilirubinemia, Neonatal Jaundice
Conditions
Keywords
Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn
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.
Interventions
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.
OTHERvisual 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.
Sponsors
Princess Amalia Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
24 Hours to 8 Days
Healthy volunteers
No
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). | up to 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit' | up to 1 year | — |
| Highest Measured Serum Bilirubin-value | up to 1 year | — |
| Number of Patients Having Kernicterus | up to 1 year | Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Transcutaneous Bilirubin Measurements patients that were randomized to get bilirubine measurements through the transcutaneous bilirubinometer | 213 |
| Visual Assessment of Neonatal Jaundice patients that were randomized NOT to get bilirubinemeasurements through the transcutaneous bilirubinometer | 217 |
| Total | 430 |
Baseline characteristics
| Characteristic | Visual Assessment of Neonatal Jaundice | Transcutaneous Bilirubin Measurements | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 217 Participants | 213 Participants | 430 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous agee | 59.2 hours STANDARD_DEVIATION 19.8 | 53.9 hours STANDARD_DEVIATION 17.4 | 56.6 hours STANDARD_DEVIATION 18.6 |
| Region of Enrollment Netherlands | 217 Participants | 213 Participants | 430 Participants |
| Sex: Female, Male Female | 98 Participants | 103 Participants | 201 Participants |
| Sex: Female, Male Male | 119 Participants | 110 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 213 | 0 / 217 |
| other Total, other adverse events | 0 / 213 | 0 / 217 |
| serious Total, serious adverse events | 0 / 213 | 0 / 217 |
Outcome results
Primary
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
Time frame: up to 1 year
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Transcutaneous Bilirubin Measurements | Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). | 0 blood tests for bilirubin |
| Visual Assessment of Neonatal Jaundice | Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). | 1 blood tests for bilirubin |
Secondary
Highest Measured Serum Bilirubin-value
Time frame: up to 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transcutaneous Bilirubin Measurements | Highest Measured Serum Bilirubin-value | 210 micromol/l | Standard Deviation 46 |
| Visual Assessment of Neonatal Jaundice | Highest Measured Serum Bilirubin-value | 217 micromol/l | Standard Deviation 65 |
Secondary
Number of Patients Having Kernicterus
Kernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Time frame: up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Bilirubin Measurements | Number of Patients Having Kernicterus | 0 Participants |
| Visual Assessment of Neonatal Jaundice | Number of Patients Having Kernicterus | 0 Participants |
Secondary
Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
Time frame: up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transcutaneous Bilirubin Measurements | Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit' | 3 Participants |
| Visual Assessment of Neonatal Jaundice | Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit' | 1 Participants |