Indocyanine Green for Neonatal Cholestasis

Overseen By Samuel Hagman, DO, DO

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Alabama at Birmingham

Disqualifiers: Outpatient management, Non-cholestatic, TPN and NPO, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Indocyanine Green (ICG) to help diagnose biliary atresia in infants with neonatal cholestasis. Biliary atresia occurs when bile ducts are blocked, and the trial aims to determine if ICG can accurately show bile flow. Infants admitted to the hospital for suspected biliary atresia and requiring further tests might be suitable candidates. The study involves administering a one-time IV dose of ICG and checking the infant's diapers for the dye, which would indicate proper bile flow. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering a chance to contribute to groundbreaking medical advancements.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Indocyanine Green is safe for infants?

Research has shown that Indocyanine Green (ICG) is generally safe for use in medical procedures. In surgical studies, ICG was well-tolerated and safe for diagnosing conditions like biliary atresia, a liver issue affecting bile ducts, in infants. Another review found that using ICG in surgeries for children did not cause significant harm to newborns.

Although this trial is in an early stage with limited safety data, past use of ICG in medical settings supports its safety. The studies reviewed have reported no major negative side effects linked to ICG. Overall, ICG appears to be a safe option for diagnosing problems with bile flow in infants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Indocyanine Green is unique because it offers a new way to diagnose neonatal cholestasis by helping to identify biliary atresia, a serious liver condition in infants. Unlike traditional diagnostic methods, such as liver biopsies or invasive imaging techniques, Indocyanine Green is a dye that can be administered intravenously and helps visualize liver function in real-time. Researchers are excited about this treatment because it could potentially provide quicker and less invasive diagnostics, improving outcomes for affected infants by enabling earlier and more accurate treatment planning.

What evidence suggests that Indocyanine Green is effective for assessing biliary patency in neonatal cholestasis?

Research has shown that Indocyanine Green (ICG), administered to participants in this trial, can help assess bile flow in newborns with liver issues. Tests have demonstrated that ICG is 97% accurate in confirming proper bile movement. This accuracy is crucial for diagnosing conditions like biliary atresia, where bile ducts are blocked. The ICG test involves administering a special dye detectable if bile is flowing. Studies indicate that ICG is a safe and effective method for examining the small bile ducts of infants. ^{1 6 7 8 9}

Who Is on the Research Team?

Laura Stafman, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for infants with symptoms that may indicate biliary atresia or other conditions causing neonatal cholestasis and jaundice. The study involves additional testing to the standard workup for these conditions.

Inclusion Criteria

My baby is in the hospital for suspected 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

My infant does not have cholestasis.

I am on total parenteral nutrition and not eating by mouth for reasons not related to temporary procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a one-time intravenous (IV) dose of Indocyanine Green (ICG) to assess biliary patency

1 day

1 visit (in-person)

Follow-up

Participants are monitored for the presence of ICG in diapers to assess bile flow

72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview The trial tests a one-time IV dose of Indocyanine Green (ICG) in infants. It aims to check if ICG can be detected in diapers, indicating bile flow, which would help diagnose biliary patency in neonatal cholestasis.

How Is the Trial Designed?

Group I: Cholestatic infants Experimental Treatment 1 Intervention

infants that are cholestatic needing further work up for biliary atresia

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38996159/

Role of indocyanine green-guided near-infrared ... In total, 16 NC patients were included in the study, comprising 8 (50%) male and 8 (50%) female patients, ranging in age from 42 to 93 days, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07250854?lastUpdPost=2020-01-16_

Study Details | NCT07250854 | The Use of Near-Infrared ... Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis. These data include demographics, such as age, sex/gender, race and ethnicity, and study- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S002234681930569X

The outcome of real-time evaluation of biliary flow using ... The aim of this study was to evaluate the utility of near-infrared fluorescence cholangiography (NIR-FCG) with ICG in primary surgery for biliary atresia (BA).

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2022.1005879/full

Intraoperative indocyanine green fluorescence ... Intraoperative indocyanine green fluorescence cholangiography can rule out biliary atresia: A preliminary report Frontiers in Pediatrics

5. mdpi.com mdpi.com/2227-9067/12/7/950

Indocyanine Green Fluorescence Navigation in Pediatric ... Conclusions: ICG fluorescence navigation in pediatric hepatobiliary surgery is a highly promising and safe technology that allows for the intraoperative ...

6. journals.lww.com journals.lww.com/md-journal/fulltext/2024/07120/role_of_indocyanine_green_guided_near_infrared.72.aspx

Role of indocyanine green-guided near-infrared ... We conducted this retrospective study to evaluate whether ICG injection followed by NIRF imaging can accurately and safely diagnose neonatal BA during surgery.

7. jpedsurg.org jpedsurg.org/article/S0022-3468(22)00711-4/fulltext

Safety and Feasibility of Indocyanine Green Fluorescence ... This systematic review analyzes whether ICG is useful for intestinal perfusion assessment in pediatric gastrointestinal surgery and safe to use in neonates.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07250854?locStr=United+States&country=United+States

Study Details | NCT07250854 | The Use of Near-Infrared ... This was described as 97% accurate for assessing biliary patency and we would like to perform a similar study to assess biliary patency in the work up of ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11245186/

Role of indocyanine green-guided near-infrared ... ICG-guided NIRF is associated with an easy operation, less trauma, and good safety. Also, its diagnostic accuracy is similar to conventional laparoscopic bile ...