Enteral Fish Oil is Superior to Ursodeoxycholic Acid (UDCA) and Placebo for the Treatment of Cholestasis in Infants

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Cholestasis, Liver Disease

In brief

To investigate the effect of enteral fish oil and UDCA on the time of cholestasis resolution and other markers of parenteral nutrition-associated liver disease.

Key facts

Study ID

NCT02420496

Run by

The University of Texas Health Science Center at San Antonio

People needed

0

Starts

2016-06-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-21

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:
• Are >14 days old and <24 months of age
• Have a serum direct bilirubin of ≥2 mg/dL
• Are receiving <3 g/k/day of Intralipid via TPN
• Are expected to remain hospitalized for at least an additional 21 days

You may not qualify if…

• Have a congenitally lethal condition (e.g. Trisomy 13)
• Have clinically severe bleeding not able to be managed with routine measures
• Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis
• Have other health problems such that survival is extremely unlikely even if cholestasis improves
• Known allergy to eggs or fish products
• Receiving IV Fish oil
• Phenobarbital therapy at enrollment

Where it is running

• University Hospital — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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