CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Fish-oil emulsions +1 moredietary
Likely dose
Not stated in record
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Search/NCT01875510
NCT01875510N/ACompleted
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The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity

Dr. Sami Ulus Children's Hospital·interventional·Posted Jun 11, 2013·Updated Jul 8, 2014

In Brief

A clinical study evaluating Fish-oil emulsions and soybean-oil emulsion for Retinopathy of Prematurity and Neonatal Cholestasis. Completed, enrolled 80 participants across 1 site.

Detailed Summary

Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRetinopathy of Prematurity, Neonatal Cholestasis
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2013
Enrollment StartJan 1, 2013
Primary CompletionSep 1, 2013
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.1 years ago

Interventions

Fish-oil emulsionsdietary

Fish -oil emulsions: Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.

soybean-oil emulsiondietary

soybean-oil emulsion