Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy
Primary Purpose
Jaundice, Neonatal
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous Bilirubin Meter - 'Bilimeter'
Sponsored by
About this trial
This is an interventional diagnostic trial for Jaundice, Neonatal focused on measuring Jaundice, Neonate, Transcutaneous, Phototherapy, Bilirubin
Eligibility Criteria
Inclusion Criteria:
- Well neonates
- 35+0 weeks gestation or greater, over 24 hours old
- Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde
Exclusion Criteria:
- Unwell neonates
- Less than 35+0 weeks' gestation
- Less than 24 hours old
- Mother unable or too distressed to give informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Participating group of neonates
Arm Description
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.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
Full Information
NCT ID
NCT04719104
First Posted
January 11, 2021
Last Updated
January 20, 2021
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT04719104
Brief Title
Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy
Official Title
Can Transcutaneous Bilirubin (TcB) Measurements be Utilised to Assess Rebound Hyperbilirubinaemia Following Phototherapy in Neonates?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal
Keywords
Jaundice, Neonate, Transcutaneous, Phototherapy, Bilirubin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participating group of neonates
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Bilirubin Meter - 'Bilimeter'
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice
Description
Can the TcB be safely and effectively used to assess rebound hyperbilirubinaemia after phototherapy in babies of 35 weeks' gestation or greater?
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Well neonates
35+0 weeks gestation or greater, over 24 hours old
Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde
Exclusion Criteria:
Unwell neonates
Less than 35+0 weeks' gestation
Less than 24 hours old
Mother unable or too distressed to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Mactier, MBChB
Phone
0141 2013361
Email
Helen.Mactier@glasgow.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Frances Butterworth, MBChB
Email
Frances.butterworth3@nhs.scot
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy
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