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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 2 Weeks and 4 Months
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cholestatic infants 		infants that are cholestatic needing further work up for biliary atresia
  • Drug: Indocyanine Green
    Optical imaging agent
    Other names:
    • ICG

Recruiting Locations

University of Alabama At Birmingham
Birmingham 4049979, Alabama 4829764 35233
Contact:
samuel hagman, DO
2056389801
sehagman@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Samuel Hagman, DO, DO
2056389801
sehagman@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.