Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy

Can Transcutaneous Bilirubin (TcB) Measurements be Utilised to Assess Rebound Hyperbilirubinaemia Following Phototherapy in Neonates?

Sponsors

Lead Sponsor: NHS Greater Glasgow and Clyde

Source NHS Greater Glasgow and Clyde
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.

Overall Status Not yet recruiting
Start Date 2021-04-01
Completion Date 2021-10-01
Primary Completion Date 2021-10-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice 6 months
Enrollment 200
Condition
Intervention

Intervention Type: Device

Intervention Name: Transcutaneous Bilirubin Meter - 'Bilimeter'

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.

Arm Group Label: Participating group of neonates

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

Gender:

All

Minimum Age:

N/A

Maximum Age:

14 Days

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Helen Mactier, MBChB

Phone: 0141 2013361

Email: [email protected]

Verification Date

2021-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Participating group of neonates

Type: Experimental

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.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

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

Masking: None (Open Label)

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