The Influence of Fish-oil Lipid Emulsions on Neonatal Morbidities

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Retinopathy of Prematurity, Neonatal Cholestasis

Intervention / Treatment
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* Dietary Supplement: Fish-oil emulsions
* Dietary Supplement: soybean-oil emulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants below 32 gestational age and requiring parenteral nutrition Exclusion Criteria: Infants with congenital anomalies, infants above 32 gestational age

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fish-oil emulsions<br>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: Fish-oil emulsions<br>* 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.<br>* Other names: Smoflipid;Dietary Supplement: soybean-oil emulsion<br>* soybean-oil emulsion<br>* Other names: Intralipid;|
| Placebo Comparator: soybean-oil emulsion<br>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 | Dietary Supplement: Fish-oil emulsions<br>* 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.<br>* Other names: Smoflipid;Dietary Supplement: soybean-oil emulsion<br>* soybean-oil emulsion<br>* Other names: Intralipid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Retinopathy of Prematurity | The number of Participants with Retinopathy of Prematurity will be defined. | Corrected age 32 weeks or postnatal 28th day |