Jaundice, NeonatalNCT04719104
Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy
A study testing Transcutaneous Bilirubin Meter - 'Bilimeter' in people with Jaundice, Neonatal, run by NHS Greater Glasgow and Clyde.
Trial summary
Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates? Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Jaundice, Neonatal
- What is being tested?
- Transcutaneous Bilirubin Meter - 'Bilimeter'
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Well neonates
- 35+0 weeks gestation or greater, over 24 hours old
- Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde
Who cannot join
- Unwell neonates
- Less than 35+0 weeks' gestation
- Less than 24 hours old
- Mother unable or too distressed to give informed consent
Trial locations and contacts
No sites are listed yet.
Frances Butterworth, MBChB contact
About this study
Official title: Can Transcutaneous Bilirubin (TcB) Measurements be Utilised to Assess Rebound Hyperbilirubinaemia Following Phototherapy in Neonates?
Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?
Read the detailed description
Jaundice is common in the newborn and may result in the need for babies to be readmitted from home for phototherapy, with associated increased costs and significant family distress.
As well as prolonged hospital stay, neonates on phototherapy require multiple blood tests (SBR), generally acquired via heel prick testing. These cause the baby discomfort and samples may be insufficient or haemolyzed and require repeating. There is also a delay of one to two hours at best in results being received and actioned.
Jaundice measurements can also be obtained using non-invasive, cheap and reliable meters (TcB) that give almost immediate results. The meter takes one to two minutes to get a result and can be used at the cotside. TcB causes the baby no significant discomfort.
TcB meters are commonly used before phototherapy but are not routinely used during or after stopping phototherapy. Jaundice commonly worsens after stopping phototherapy due to release of bilirubin from tissues and so measuring a "rebound" SBR twelve hours after stopping phototherapy and before the baby can go home is routine practice.
TcB meters tend to underestimate SBR in the first eight hours after stopping phototherapy but there is some evidence that thereafter they may provide reliable results. If TcB measurements can be used as a reliable predictor for SBR twelve hours after phototherapy, this will reduce blood sampling and costs, causing less distress to the baby and their mother, with potential for earlier discharge home. The NICE guideline for neonatal jaundice suggests that new research is needed to evaluate the accuracy of different transcutaneous bilirubinometers in comparison to serum bilirubin levels in all babies.
- Conditions
- Jaundice, Neonatal
- Being tested
- Transcutaneous Bilirubin Meter - 'Bilimeter'
- Keywords
- Jaundice, Neonate, Transcutaneous, Phototherapy, Bilirubin
- Medical subject headings
- Jaundice, Neonatal, Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Bilirubin Meter - 'Bilimeter'Device
Taking a transcutaneous (TcB) measurement will involve using a 'biliflash'. This is a non-invasive measurement that involves flashing a light against the helix of the infant's ear and can be done at the cotside. This process takes approximately 1-2 minutes and does not cause the baby discomfort. The meter gives an immediate bilirubin level.
| Study group | Role | What they receive |
|---|---|---|
| Participating group of neonates | Experimental | Participating group: Neonates that have had both a serum bilirubin measurement and transcutaneous measurement post phototherapy. This is a single arm study as we are only targeting one group of individuals with the intervention (transcutaneous bilirubin measurement). However, we will compare the serum bilirubin measurement to the transcutaneous measurement from the same neonate to determine if there is a clinically significant difference between the two measurements. Receives: Device: Transcutaneous Bilirubin Meter - 'Bilimeter' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice
Can the TcB be safely and effectively used to assess rebound hyperbilirubinaemia after phototherapy in babies of 35 weeks' gestation or greater?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, NeonatalStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study population will include 200 newborns of 35 weeks' gestation or greater who are over 24 hours old. Each baby will be studied only once. In addition to the routine SBR (capillary blood sample to measure serum bilirubin (jaundice), a paired TcB measurement will be taken 10-14 hours after stopping phototherapy. Taking a TcB measurement will involve using a 'biliflash'. This is a non-invasive measurement that flashes a light against the baby's ear and can be done at the cotside. The test takes less than a minute and does not cause the baby discomfort.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719104
- Sponsor's protocol ID
- GN20HP515
- Status last verified
- Jan 2021
- First submitted
- 11 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Transcutaneous Bilirubin (TcB) Measurements be Utilised to Assess Rebound Hyperbilirubinaemia Following Phototherapy in Neonates?
- ClinicalTrials.gov ID
- NCT04719104
- Acronym / sponsor ID
- GN20HP515
- Conditions
- Jaundice, Neonatal
- Keywords
- Jaundice, Neonate, Transcutaneous, Phototherapy, Bilirubin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?
Detailed description
Jaundice is common in the newborn and may result in the need for babies to be readmitted from home for phototherapy, with associated increased costs and significant family distress.
As well as prolonged hospital stay, neonates on phototherapy require multiple blood tests (SBR), generally acquired via heel prick testing. These cause the baby discomfort and samples may be insufficient or haemolyzed and require repeating. There is also a delay of one to two hours at best in results being received and actioned.
Jaundice measurements can also be obtained using non-invasive, cheap and reliable meters (TcB) that give almost immediate results. The meter takes one to two minutes to get a result and can be used at the cotside. TcB causes the baby no significant discomfort.
TcB meters are commonly used before phototherapy but are not routinely used during or after stopping phototherapy. Jaundice commonly worsens after stopping phototherapy due to release of bilirubin from tissues and so measuring a "rebound" SBR twelve hours after stopping phototherapy and before the baby can go home is routine practice.
TcB meters tend to underestimate SBR in the first eight hours after stopping phototherapy but there is some evidence that thereafter they may provide reliable results. If TcB measurements can be used as a reliable predictor for SBR twelve hours after phototherapy, this will reduce blood sampling and costs, causing less distress to the baby and their mother, with potential for earlier discharge home. The NICE guideline for neonatal jaundice suggests that new research is needed to evaluate the accuracy of different transcutaneous bilirubinometers in comparison to serum bilirubin levels in all babies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population will include 200 newborns of 35 weeks' gestation or greater who are over 24 hours old. Each baby will be studied only once. In addition to the routine SBR (capillary blood sample to measure serum bilirubin (jaundice), a paired TcB measurement will be taken 10-14 hours after stopping phototherapy. Taking a TcB measurement will involve using a 'biliflash'. This is a non-invasive measurement that flashes a light against the baby's ear and can be done at the cotside. The test takes less than a minute and does not cause the baby discomfort.
| Arm | Type | Receives |
|---|---|---|
| Participating group of neonates | Experimental | Device: Transcutaneous Bilirubin Meter - 'Bilimeter'Participating group: Neonates that have had both a serum bilirubin measurement and transcutaneous measurement post phototherapy. This is a single arm study as we are only targeting one group of individuals with the intervention (transcutaneous bilirubin measurement). However, we will compare the serum bilirubin measurement to the transcutaneous measurement from the same neonate to determine if there is a clinically significant difference between the two measurements. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Well neonates
- 35+0 weeks gestation or greater, over 24 hours old
- Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde
Key exclusion criteria (4 listed)
- Unwell neonates
- Less than 35+0 weeks' gestation
- Less than 24 hours old
- Mother unable or too distressed to give informed consent
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 Bilirubin Meter - 'Bilimeter'Taking a transcutaneous (TcB) measurement will involve using a 'biliflash'. This is a non-invasive measurement that involves flashing a light against the helix of the infant's ear and can be done at the cotside. This process takes approximately 1-2 minutes and does not cause the baby discomfort. The meter gives an immediate bilirubin level. | Device | Participating group of neonates |
Primary outcome
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice
Time frame: 6 months
Can the TcB be safely and effectively used to assess rebound hyperbilirubinaemia after phototherapy in babies of 35 weeks' gestation or greater?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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.
Frances Butterworth, MBChB contact
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Bilirubin Meter - 'Bilimeter' in people with Jaundice, Neonatal, run by NHS Greater Glasgow and Clyde.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helen Mactier, MBChB (0141 2013361, Helen.Mactier@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.