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NCT04586608 Clinical Trial

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

Premature Birth Clinical Trial

— MCT/?-3 FA  

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04586608
Other study ID # 201802
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2018
Est. completion date May 15, 2020

Study information
Verified date October 2020
Source Iaso Maternity Hospital, Athens, Greece
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date May 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• MCT/?-3 fatty acids
The provision of ?-3 fatty acids to premature neonates in the Parenteral Nutrition.
• soybean oil-based IVFE
soybean oil-based IVFE

Locations
Country Name City State
Greece Panos Papandreou Athens

Sponsors (1)
Lead Sponsor Collaborator
Iaso Maternity Hospital, Athens, Greece

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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/?-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/?-3 PUFA-enriched IVFE group compared to the SO-IVFE group post intervention.		 two years
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