Trial Outcomes & Findings for Implementation of a Transcutaneous Bilirubinometer (NCT NCT01622699)
NCT ID: NCT01622699
Last Updated: 2020-01-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
430 participants
Primary outcome timeframe
up to 1 year
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Transcutaneous Bilirubin Measurements
patients that were randomized to get bilirubinemeasurements through the transcutaneous bilirubinometer
|
Visual Assessment of Neonatal Jaundice
pateients that were randomized to the standrad treatemnt, thus withoutthe use of the transcutaneous bilirubinometer
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
217
|
|
Overall Study
COMPLETED
|
213
|
217
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of a Transcutaneous Bilirubinometer
Baseline characteristics by cohort
| Measure |
Transcutaneous Bilirubin Measurements
n=213 Participants
patients that were randomized to get bilirubine measurements through the transcutaneous bilirubinometer
|
Visual Assessment of Neonatal Jaundice
n=217 Participants
patients that were randomized NOT to get bilirubinemeasurements through the transcutaneous bilirubinometer
|
Total
n=430 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
213 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
agee
|
53.9 hours
STANDARD_DEVIATION 17.4 • n=5 Participants
|
59.2 hours
STANDARD_DEVIATION 19.8 • n=7 Participants
|
56.6 hours
STANDARD_DEVIATION 18.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
213 Participants
n=5 Participants
|
217 Participants
n=7 Participants
|
430 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearOutcome measures
| Measure |
Transcutaneous Bilirubin Measurements
n=213 Participants
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
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.
|
Visual Assessment of Neonatal Jaundice
n=217 Participants
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
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).
|
0 blood tests for bilirubin
Interval 0.0 to 2.0
|
1 blood tests for bilirubin
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
| Measure |
Transcutaneous Bilirubin Measurements
n=213 Participants
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
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.
|
Visual Assessment of Neonatal Jaundice
n=217 Participants
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
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 Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 1 yearOutcome measures
| Measure |
Transcutaneous Bilirubin Measurements
n=213 Participants
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
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.
|
Visual Assessment of Neonatal Jaundice
n=217 Participants
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
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.
|
|---|---|---|
|
Highest Measured Serum Bilirubin-value
|
210 micromol/l
Standard Deviation 46
|
217 micromol/l
Standard Deviation 65
|
SECONDARY outcome
Timeframe: up to 1 yearKernicterus is a very rare condition. As it is a possible complication of neonatal hyperbilirubinemia, it's an outcome measure.
Outcome measures
| Measure |
Transcutaneous Bilirubin Measurements
n=213 Participants
In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer
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.
|
Visual Assessment of Neonatal Jaundice
n=217 Participants
In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician
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 Patients Having Kernicterus
|
0 Participants
|
0 Participants
|
Adverse Events
Transcutaneous Measurement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visual Assessment of Neonatal Jaundice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place