Neonatal JaundiceNCT01622699
Implementation of a Transcutaneous Bilirubinometer
A study testing Transcutaneous Bilirubinometer and visual assessment of neonatal jaundice in people with Neonatal Jaundice and Hyperbilirubinemia, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 hours to 8 days
- Conditions the study is for
- Neonatal Jaundice, Hyperbilirubinemia
- What is being tested?
- Transcutaneous Bilirubinometer and visual assessment of neonatal jaundice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2013to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 hours to 8 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Isala Klinieken, Amalia Childrens Clinic
Zwolle, Overijssel, 8025AB
About this study
Official title: Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
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
Read the 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.
- Conditions
- Neonatal Jaundice, Hyperbilirubinemia
- Being tested
- Transcutaneous Bilirubinometer, visual assessment of neonatal jaundice
- Keywords
- Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn
- Medical subject headings
- Jaundice, Neonatal, Hyperbilirubinemia, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous BilirubinometerDevice
Also called JaundiceMeter-103®, Dräger
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 jaundiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous bilirubin measurements | Experimental | In this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer Receives: Device: Transcutaneous Bilirubinometer |
| Visual assessment of neonatal jaundice | Active comparator | In this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician Receives: Other: visual assessment of neonatal jaundice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
Measured: up to 1 year
Secondary outcomes (3)
Number of Patients With Serum Bilirubin-values Above the 'Exchange Transfusion Limit'
Measured: up to 1 year
Highest Measured Serum Bilirubin-value
Measured: up to 1 year
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2012 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Amalia Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolita Bekhof, MD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01622699
- Sponsor's protocol ID
- TcB AmaliaCC
- Status last verified
- Dec 2019
- First submitted
- 12 Jun 2012
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.
PubMed 15231951Dijk PH, de Vries TW, de Beer JJ; Dutch Pediatric Association. [Guideline 'Prevention, diagnosis and treatment of hyperbilirubinemia in the neonate with a gestational age of 35 or more weeks']. Ned Tijdschr Geneeskd. 2009;153:A93. Dutch.
PubMed 19785881Szabo P, Wolf M, Bucher HU, Fauchere JC, Haensse D, Arlettaz R. Detection of hyperbilirubinaemia in jaundiced full-term neonates by eye or by bilirubinometer? Eur J Pediatr. 2004 Dec;163(12):722-7. doi: 10.1007/s00431-004-1533-7.
PubMed 15365826van den Esker-Jonker B, den Boer L, Pepping RM, Bekhof J. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016 Dec;138(6):e20162414. doi: 10.1542/peds.2016-2414. Epub 2016 Nov 4.
PubMed 27940715
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Transcutaneous Bilirubinometer in Jaundiced Newborns: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01622699
- Acronym / sponsor ID
- TcB AmaliaCC
- Conditions
- Neonatal Jaundice, Hyperbilirubinemia
- Keywords
- Jaundice, Neonatal Jaundice, Hyperbilirubinemia, Transcutaneous bilirubin measurement, Transcutaneous bilirubinometry, jaundice meter, Visual assessment of bilirubin, Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Princess Amalia Children's ClinicUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Jun 2012 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous bilirubin measurements | Experimental | Device: Transcutaneous BilirubinometerIn this intervention group, the initial visual assessment of jaundice wille be followed by measurement by transcutaneous bilirubinometer |
| Visual assessment of neonatal jaundice | Active comparator | Other: visual assessment of neonatal jaundiceIn this control group (standard of care) the visual assessment will be followed by measurement of blood bilirubin as indicated by the physician |
Who may qualify
- Ages
- 24 hours to 8 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous BilirubinometerAlso: JaundiceMeter-103®, DrägerIf 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. | Device | Transcutaneous bilirubin measurements |
| visual assessment of neonatal jaundiceTo 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. | Other | Visual assessment of neonatal jaundice |
Primary outcome
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy).
Time frame: up to 1 year
3 secondary outcomes
Number of Patients With 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
Number of Patients Having Kernicterus
Time frame: up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15231951American Academy of Pediatrics Subcommittee on Hyperbilirubinemia. Management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation. Pediatrics. 2004 Jul;114(1):297-316. doi: 10.1542/peds.114.1.297.
- Background: PubMed 19785881Dijk PH, de Vries TW, de Beer JJ; Dutch Pediatric Association. [Guideline 'Prevention, diagnosis and treatment of hyperbilirubinemia in the neonate with a gestational age of 35 or more weeks']. Ned Tijdschr Geneeskd. 2009;153:A93. Dutch.
- Background: PubMed 15365826Szabo P, Wolf M, Bucher HU, Fauchere JC, Haensse D, Arlettaz R. Detection of hyperbilirubinaemia in jaundiced full-term neonates by eye or by bilirubinometer? Eur J Pediatr. 2004 Dec;163(12):722-7. doi: 10.1007/s00431-004-1533-7.
- Derived from this study: PubMed 27940715van den Esker-Jonker B, den Boer L, Pepping RM, Bekhof J. Transcutaneous Bilirubinometry in Jaundiced Neonates: A Randomized Controlled Trial. Pediatrics. 2016 Dec;138(6):e20162414. doi: 10.1542/peds.2016-2414. Epub 2016 Nov 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolita Bekhof, MD principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Bilirubinometer and visual assessment of neonatal jaundice in people with Neonatal Jaundice and Hyperbilirubinemia, run by Princess Amalia Children's Clinic at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Blood Tests for Bilirubin Measurement (Before the Potential Start of Phototherapy). (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01622699, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.