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

• Status: Withdrawn
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

Neonates admitted to the Neonatal Intensive Care Unit (NICU) at University Hospital (UH) in San Antonio, Texas, who:

1. Are >14 days old and <24 months of age

2. Have a serum direct bilirubin of ≥2 mg/dL

3. Are receiving <3 g/k/day of Intralipid via TPN

4. Are expected to remain hospitalized for at least an additional 21 days

Exclusion Criteria:

1. Have a congenitally lethal condition (e.g. Trisomy 13)

2. Have clinically severe bleeding not able to be managed with routine measures

3. Have evidence of a viral hepatitis or primary liver disease as the etiology of their cholestasis

4. Have other health problems such that survival is extremely unlikely even if cholestasis improves

5. Known allergy to eggs or fish products

6. Receiving IV Fish oil

7. Phenobarbital therapy at enrollment