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

NCT ID: NCT04586608

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2020-05-15

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.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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active comparator

Group Type ACTIVE_COMPARATOR

MCT/ω-3 fatty acids

Intervention Type DIETARY_SUPPLEMENT

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

soybean oil-based IVFE

soybean oil-based IVFE

Group Type OTHER

soybean oil-based IVFE

Intervention Type DIETARY_SUPPLEMENT

soybean oil-based IVFE

Interventions

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MCT/ω-3 fatty acids

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

Intervention Type DIETARY_SUPPLEMENT

soybean oil-based IVFE

soybean oil-based IVFE

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

0 Days

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iaso Maternity Hospital, Athens, Greece

OTHER

Sponsor Role lead

Responsible Party

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Panos Papandreou

pharmD PhDc Head of Parenteral Nutrition Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Panos Papandreou

Athens, , Greece

Site Status

Countries

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Greece

Other Identifiers

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201802

Identifier Type: -

Identifier Source: org_study_id

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