Cholestasis, Liver Disease
Conditions
Keywords
Parental nutrition, associated
Brief 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.
Interventions
DRUGEnteral fish oil
DRUGUrsodeoxycholic Acid
DRUGPlacebo
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Days to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Direct Bilirubin | Evaluated every 7 days up to 180 days | Direct bilirubin less than 1 mg/dL considered resolution of cholestasis |
Countries
United States
Outcome results
None listed