NCT01875510

The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

The Effect of Fish-oil Lipid Emulsions on Neonatal Cholestasis and Retinopathy of Prematurity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

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.

Detailed description

During the study period, preterm infants admitted to NICU were included. Infants who weighed \<1500 gr and delivered prematurely before the 32nd week of gestation were eligible for the study. Infants with major congenital anomalies, congenital infections and inborn metabolic errors were excluded from the study. Group 1: Fish-oil emulsion (20% SMOFLipid: soybean oil 60 g/dL, MCT 60 g/dL, olive oil 50 g/dL, fish oil 30 g/dL, egg phospholipids 12 g/dL, glycerol 25 g/dL, vitamin E 200 mg α-TE/L) Group 2: Soybean oil emulsion (20% Intralipid: soybean oil 200 g/dL, egg phospholipids 12 g/dL, glycerol 22,5 g/dL, vitamin E 57 mg α-TE/L).

Conditions

• Retinopathy of Prematurity
• Neonatal Cholestasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fish-oil emulsions	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.
DIETARY_SUPPLEMENT	soybean-oil emulsion	soybean-oil emulsion

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• Completion: 2013-11-01
• First posted: 2013-06-11
• Last updated: 2014-07-08
• Results posted: 2014-07-08

Locations

1 site across 1 country: Turkey (Türkiye)