Clinical trial NCT04719104: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Jaundice, Neonatal
Keywords: Jaundice
Neonate
Transcutaneous
Phototherapy
Bilirubin
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
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Study officials:
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