CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
multicomponent lipid emulsion +1 moredrug
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/NCT02663453
NCT02663453Phase 3Completed

Effectiveness of Multicomponent Lipid Emulsion in Preterm Infants Requiring Parenteral Nutrition: A Two-Center, Double-Blind Randomized Clinical Trial

Thammasat University·interventional·Posted Jan 26, 2016·Updated Jun 23, 2017

In Brief

A Phase 3 clinical trial evaluating multicomponent lipid emulsion and pure soybean oil lipid emulsion for Cholestasis. Completed, enrolled 44 participants.

Detailed Summary

The purpose of this study is to compare the effects of a multicomponent lipid emulsion containing 30% soybean oil, 30% medium-chain triglycerides, 25% olive oil, and 15% fish oil with a conventional pure soybean oil lipid emulsion on the incidence of neonatal cholestasis, infant growth, infant morbidity and the biochemical assessment of liver enzymes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholestasis
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 26, 2016
Enrollment StartDec 1, 2013
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 10.4 years ago

Interventions

multicomponent lipid emulsiondrug

Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.

pure soybean oil lipid emulsiondrug

Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.