The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-03-31

Brief Summary

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In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG). The infant's diapers will subsequently be examined for presence of the ICG, and if present, suggests bile flow. 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 neonatal cholestasis.

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Detailed Description

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Conditions

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Biliary Atresia Kasai Cholestasis in Newborn Cholestasis in Newborn Infant

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cholestatic infants

infants that are cholestatic needing further work up for biliary atresia

Group Type EXPERIMENTAL

Indocyanine Green

Intervention Type DRUG

Optical imaging agent

Interventions

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Indocyanine Green

Optical imaging agent

Intervention Type DRUG

Other Intervention Names

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ICG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes