None listed
Conditions
Brief summary
Biliary atresia is a progressive, destructive process which becomes obvious over the first 3-6 months of a baby's life as they develop a specific type of jaundice and their stools become pale. Diagnosis of this in the premature and low birth weight population is difficult because the tests (ultrasound, nuclear medicine scans) are not very accurate at detecting structural changes. Our study aims to see if an alternative test, where a safe dye is injected intravenously, passes through the bloodstream and into the liver before entering the stools of babies can more accurately detect problems with the bile system. If the dye is found in the stools (dirty nappies) using a specialised camera, it shows the bile system is operating and if it is not detected, then the bile clearing system is potentially affected and the baby requires additional specialised invasive testing. If problems with the bile system can be accurately detected quickly, babies are more likely to have good response to surgery and avoided liver transplantation.
Interventions
The intervention is to inject TGA approved indocyanine green dye intravenously into neonates with cholestasis and utilise bedside flourescence imaging of the stools to detect the ICG dye presence in the stool to confirm biliary patency.
Dose of Dye will be 0.1mg/kg through intravenous catheter (IVC) once only.
Dye will be injected by beside nursing staff as per pharmacy instructions and the nappies will be collected and viewed by trained investigators using the IC-flow hand held ICG detection
The intervention is to inject TGA approved indocyanine green dye intravenously into neonates with cholestasis and utilise bedside flourescence imaging of the stools to detect the ICG dye presence in the stool to confirm biliary patency. Dose of Dye will be 0.1mg/kg through intravenous catheter (IVC) once only. Dye will be injected by beside nursing staff as per pharmacy instructions and the nappies will be collected and viewed by trained investigators using the IC-flow hand held ICG detection camera. All nappies following the intravenous dye injection will be collected for 7 days. The intervention will be performed in the neonatal intensive care unit in babies with cholestasis who will also be undergoing standard investigations for biliary atresia (liver ultrasound and scuntigraphy)
Sponsors
Canberra Health Servives
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Neonates admitted to the NICU / SCN up to 3 months corrected gestational age 2. Presenting with cholestasis defined as conjugated bilirubin >20 µmol/L or >20% of total bilirubin 3. Undergoing investigation for cause of cholestasis 4. Parent/guardian able to provide informed consent 5. Expected to remain in NICU or under care at study site for duration of diagnostic workup
Exclusion criteria
1. Known hypersensitivity to ICG or iodine 2. Known or suspected thyroid disease 3. Previous administration of ICG within 2 weeks 4. Already definitively diagnosed prior to enrolment 5. Concomitant gastrointestinal pathology that may interfere with stool collection or interpretation (e.g., intestinal obstruction, necrotizing enterocolitis, inflammatory bowel disease) 6. Severe haemodynamic instability as determined by treating neonatologist (e.g., requiring high-frequency ventilation, requiring >2 inotropes, severe hypotension unresponsive to treatment) 7. Parent/guardian unable or unwilling to provide informed consent 8. Neonates receiving palliative care or with life-limiting conditions where diagnostic workup would not alter management 9. Nil by mouth status with absent stool output
Outcome results
None listed