CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 136 enrolled
Drug / intervention
Intravenous fat emulsion +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01050660
NCT01050660N/ACompleted
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Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates

Yale University·interventional·Posted Jan 15, 2010·Updated Oct 28, 2014

In Brief

A clinical study evaluating Intravenous fat emulsion and Restriction of intravenous fat emulsion to 1 gm/kg/d for Parenteral Nutrition-Associated Liver Disease. Completed, enrolled 136 participants across 1 site.

Detailed Summary

The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParenteral Nutrition-Associated Liver Disease
CountriesUnited States
CollaboratorsUniversity of California, Los Angeles, Northwestern University

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 15, 2010
Enrollment StartJun 1, 2009
Primary CompletionNov 1, 2012
Study CompletionJan 1, 2013
TodayJul 1, 2026
Enrollment to primary: 3.4 yearsPosted 16.5 years ago

Interventions

Intravenous fat emulsionother

An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.

Restriction of intravenous fat emulsion to 1 gm/kg/dother

Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.