Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.

Study Overview
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Brief Summary
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Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational age <32 weeks, birth weight <1500g) were assigned to receive either MCT/n-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave their informed written consent for inclusion in the study. Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.

Official Title
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Administration of an Intravenous Fat Emulsion Enriched With MCT/ω-3 Fatty Acids is Beneficial Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates: a Randomized, Double-blind Clinical Trial.

Conditions
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Premature Birth

Intervention / Treatment
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* Dietary Supplement: MCT/ω-3 fatty acids
* Dietary Supplement: soybean oil-based IVFE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preterm neonates with gestational age <32 weeks birth weight <1500 g admitted to a tertiary neonatal intensive care unit within 12 hours after birth Exclusion Criteria: anticipated needs for parenteral nutrition (PN) at ˃70% of total daily energy for <10 days evidence of intrauterine infection, perinatal asphyxia major congenital anomalies refusal of parental consent

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 2 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: active comparator<br> | Dietary Supplement: MCT/ω-3 fatty acids<br>* The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.<br>|
| Other: soybean oil-based IVFE<br>soybean oil-based IVFE | Dietary Supplement: soybean oil-based IVFE<br>* soybean oil-based IVFE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alterations on Metabolic Fatty Acid Profile of the Premature Neonates | the detection of clinically significant differences in plasma n-3 PUFAs, n-6 PUFAs and EPA in the MCT/ω-3 PUFA-enriched IVFE group compared to the SO-IVFE group post intervention. the detection of clinically significant differences in plasma n-3 PUFAs, n-6 PUFAs and EPA in the MCT/ω-3 PUFA-enriched IVFE group compared to the SO-IVFE group post intervention. | two years |