Status:
UNKNOWN
Parenteral Nutrition Associated Liver Disease: Early Markers and Therapy Wih Enteral Omega-3 Supplementation
Lead Sponsor:
University of Tennessee
Conditions:
Parenteral Nutrition Associated Liver Disease
Eligibility:
All Genders
1-1 years
Phase:
NA
Brief Summary
Cholestatic liver disease is a common complication associated with long term parenteral nutrition (PN). PN associated liver disease (PNALD) is much more common in premature infants and the incidence i...
Detailed Description
Research Design and Methods Study Design. This is a two part study that includes an initial observation period when markers for PNALD are evaluated, followed by a randomized, controlled trial of enter...
Eligibility Criteria
Inclusion
- Neonates / infants \< 1 year of age (there is no minimum age for enrollment and subjects may be male or female)
- Enrolled prior to the development of PNALD
- Anticipated duration of PN of 4 weeks or greater including patients with:
- Short bowel syndrome resulting from surgical management of NEC, congenital bowel defects (omphalocele and gastroschisis), intestinal atresias, midgut volvulus, and other intestinal processes
- Functional short bowel syndrome
- Subjects must be deemed clinically stable with a life expectancy of at least 6 months before enrollment
Exclusion
- Bleeding risk (platelets count \< 50 thousand units/μL)
- Receiving aspirin or other anticoagulation agent
- Patient's who are deemed clinically unstable:
- Severe multi-system disease
- Genetic disorders
- DNR
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01157780
Start Date
October 1 2008
End Date
December 1 2014
Last Update
June 17 2011
Active Locations (1)
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1
Le Bonheur Children's Medical Center
Memphis, Tennessee, United States, 38103