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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2

Conditions: Cholestasis; Liver Disease

Treatments: Drug: Ursodeoxycholic Acid; Drug: Placebo; Drug: Enteral fish oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02420496

HSC20150165H

Details and patient eligibility

About

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.

Sex: All

Ages: 14 days to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups, including a placebo group

Enteral fish oil

Experimental group

Description:

Infants will receive enteral fish oil at a dose of 1mg/kg/day divided in two daily doses given enterally.

Treatment:

Drug: Enteral fish oil

UDCA (ursodeoxycholic acid)

Active Comparator group

Description:

Infants will receive UDCA at a dose of 10mg/kg/dose in two daily doses given enterally

Treatment:

Drug: Ursodeoxycholic Acid

Placebo

Placebo Comparator group

Description:

Infant will receive placebo in two daily doses given enterally

Treatment:

Drug: Placebo