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

Stopped early · Phase 4

Conditions studied: Cholestasis

In brief

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.

Key facts

Study ID

NCT01373918

Run by

University of California, Los Angeles

People needed

41

Starts

2010-12-01

Expected to finish

2014-07-01

Last updated by the study team

2016-06-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• congenital or acquired gastrointestinal disorder
• age less than 5 days of life

You may not qualify if…

• 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)

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Saint Louis University — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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