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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age2-4
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Indocyanine Green

    Drug

    Optical imaging agent

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Cholestatic infantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number and accuracy of ICG fluorescence in the diagnosis of biliary atresia

Measuring stool fluorescence using near infrared imaging

Time frame
Within 72 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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