Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of standard intravenous fat emulsions have implicated in the development and progression of PNAC.

In this study, neonates with congenital/acquired gastrointestinal disorders will be randomized, in a unblinded fashion, to receive either the standard dose of an intravenous omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion throughout their course of PN or until hospital discharge, death or 100 days of life, whichever comes first. The primary outcome will be the presence of cholestasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: St. Louis University
• Treatments: Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion

Criteria

Inclusion Criteria:

• congenital or acquired gastrointestinal disorder

• age less than 5 days of life

Exclusion Criteria:

• congenital intrauterine infection know to be associated with liver involvement

• known structural liver abnormalities

• known genetic disorders (trisomy 21, 13, and 18)

• inborn errors of metabolism

• infants meeting the criteria for terminal illness (ph:6.8>2 hours)