Premature Birth Clinical Trial
— MCT/?-3 FAOfficial 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.
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 |
Verified date | October 2020 |
Source | Iaso Maternity Hospital, Athens, Greece |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Greece | Panos Papandreou | Athens |
Lead Sponsor | Collaborator |
---|---|
Iaso Maternity Hospital, Athens, Greece |
Greece,
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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