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

Sponsor

Iaso Maternity Hospital, Athens, Greece (Other)

Overall Status

Completed

CT.gov ID

NCT04586608

Collaborator

(none)

Enrollment

Location

Arms

26.9

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Dietary Supplement: MCT/ω-3 fatty acids Dietary Supplement: soybean oil-based IVFE	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Supportive Care

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.

Actual Study Start Date :

Feb 15, 2018

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

May 15, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: active comparator

Dietary Supplement: MCT/ω-3 fatty acids

The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.

Other: soybean oil-based IVFE

soybean oil-based IVFE

Dietary Supplement: soybean oil-based IVFE

soybean oil-based IVFE

Outcome Measures

Primary Outcome Measures

Alterations on Metabolic Fatty Acid Profile of the Premature Neonates [two years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 2 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Panos Papandreou	Athens		Greece	15123

Sponsors and Collaborators

Iaso Maternity Hospital, Athens, Greece

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Panos Papandreou, pharmD PhDc Head of Parenteral Nutrition Unit, Iaso Maternity Hospital, Athens, Greece

ClinicalTrials.gov Identifier:

NCT04586608

Other Study ID Numbers:

201802

First Posted:

Oct 14, 2020

Last Update Posted:

Oct 19, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Oct 19, 2020