Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy

NCT04719104 | Unknown

• 1 other identifier: GN20HP515
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?

Conditions

Jaundice, Neonatal

Keywords

Jaundice; Neonate; Transcutaneous; Phototherapy; Bilirubin

Outcome Measures

Primary Outcomes (1)

• 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?

  6 months

Study Arms (1)

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.

Device: Transcutaneous Bilirubin Meter - 'Bilimeter'

Interventions

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.

Participating group of neonates

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Well neonates
• +0 weeks gestation or greater, over 24 hours old
• Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde

You may not qualify if:

• Unwell neonates
• Less than 35+0 weeks' gestation
• Less than 24 hours old
• Mother unable or too distressed to give informed consent

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

MeSH Terms

Conditions

Jaundice, Neonatal; Jaundice

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Helen Mactier, MBChB

CONTACT

0141 2013361; Helen.Mactier@glasgow.ac.uk

Frances Butterworth, MBChB

CONTACT

Frances.butterworth3@nhs.scot

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 22, 2021
• Study Start: April 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 22, 2021

Record last verified: 2021-01