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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
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Jaundice, Neonatal focused on measuring Jaundice, Neonate, Transcutaneous, Phototherapy, Bilirubin

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 11, 2021
    Last Updated
    January 20, 2021
    Sponsor
    NHS Greater Glasgow and Clyde
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    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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