The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

Not Applicable

Completed

• Conditions: Neonatal Cholestasis; Retinopathy of Prematurity
• Interventions: Dietary Supplement: Fish-oil emulsions; Dietary Supplement: soybean-oil emulsion

• Registration Number: NCT01875510
• Lead Sponsor: Dr. Sami Ulus Children's Hospital

Brief 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).

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Primary Completion: 2013-09
• Study Completion: 2013-11
• Results First Submitted: 2013-11-11
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Results First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Infants below 32 gestational age and requiring parenteral nutrition

Exclusion Criteria

• Infants with congenital anomalies, infants above 32 gestational age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Retinopathy of Prematurity	Corrected age 32 weeks or postnatal 28th day	The number of Participants with Retinopathy of Prematurity will be defined.

Trial Locations

Locations (1)

Dr. Sami Ulus Childrens Hospital; 🇹🇷 Ankara, Turkey