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

NCT04586608 | Completed DMC

• 1 other identifier: 201802
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

active comparator

ACTIVE COMPARATOR

Dietary Supplement: MCT/ω-3 fatty acids

soybean oil-based IVFE

OTHER

soybean oil-based IVFE

Dietary Supplement: soybean oil-based IVFE

Interventions

MCT/ω-3 fatty acids DIETARY_SUPPLEMENT

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

active comparator

soybean oil-based IVFE DIETARY_SUPPLEMENT

soybean oil-based IVFE

soybean oil-based IVFE

Eligibility Criteria

• Age: 0 Days - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates with gestational age \<32 weeks
• birth weight \<1500 g
• admitted to a tertiary neonatal intensive care unit within 12 hours after birth

You may not qualify if:

• 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

Sponsors & Collaborators

• Iaso Maternity Hospital, Athens, Greece: lead

Study Sites (1)

Panos Papandreou

Athens, 15123, Greece

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pharmD PhDc Head of Parenteral Nutrition Unit

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 14, 2020
• Study Start: February 15, 2018
• Primary Completion: February 15, 2020
• Study Completion: May 15, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

GR (1)