Using near-infrared ICG dye to check bile flow in newborns with cholestasis
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
We will give eligible newborns a single IV dose of indocyanine green (ICG) to see if the dye appears in their diapers, which would indicate bile is flowing and the bile ducts are open.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 2 Weeks to 4 Months |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07250854 on ClinicalTrials.gov |
What this trial studies
This single-center early-phase study at the University of Alabama at Birmingham will administer a one-time intravenous dose of indocyanine green (ICG) to infants admitted for an inpatient workup of neonatal cholestasis when biliary atresia is suspected. Clinical staff will subsequently examine diapers for fluorescent ICG as a sign of bile excretion and biliary patency. The protocol excludes outpatients, infants on prolonged TPN who are NPO for non-temporary reasons, and infants with prior bowel surgery that can introduce blood into the gastrointestinal tract. The team aims to reproduce previously reported high accuracy of ICG dye detection to inform faster, less invasive diagnostic pathways for neonatal cholestasis.
Who should consider this trial
Good fit: Infants admitted for inpatient workup of cholestasis with clinical concern for biliary atresia, who are not on prolonged TPN and have no history of bowel resection, are ideal candidates.
Not a fit: Infants managed entirely as outpatients, those without cholestasis, infants on prolonged TPN and NPO for non-temporary reasons, or those with prior bowel surgery are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, this could provide a quick bedside, noninvasive way to confirm bile flow and reduce the need for more invasive testing or diagnostic delays.
How similar studies have performed: Previous reports described near-infrared ICG detection in stool as about 97% accurate for biliary patency, but data specifically in the neonatal inpatient population are limited and this study seeks to replicate those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants admitted to the hospital (no matter their age, sex, race/ethnicity) who a hepatologist deems warrants inpatient work up of neonatal cholestasis suspected to be due to biliary atresia. Exclusion Criteria: * Infants that a hepatologist has not deemed to warrant inpatient admission for work up of neonatal cholestasis suspected to be due to biliary atresia. * Infants that are managed in the outpatient setting * Non-cholestatic infants * Patient who are on TPN AND NPO for reasons other than temporary imaging or surgical requirements * Infant with a history of bowel resection or other surgical procedures known to introduce blood into the gastrointestinal tract.
Where this trial is running
Birmingham, Alabama
- University of Alabama At Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Laura Stafman, MD — University of Alabama at Birmingham
- Study coordinator: Samuel Hagman, DO, DO
- Email: sehagman@uabmc.edu
- Phone: 2056389801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.