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NCT04586608: MCT/ω-3 FA
Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.
NA trial testing MCT/ω-3 fatty acids in Premature Birth in 92 participants. Completed in 15 May 2020.
15 February 2020
Quick facts
| Lead sponsor | Iaso Maternity Hospital, Athens, Greece |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | supportive care |
| Enrollment | 92 |
| Start date | 15 February 2018 |
| Primary completion | 15 February 2020 |
| Estimated completion | 15 May 2020 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- MCT/ω-3 fatty acids
- soybean oil-based IVFE
Conditions studied
- Premature Birth — all drugs for Premature Birth →
Sponsor
Iaso Maternity Hospital, Athens, Greece
Who can join
Adults 0 Days to 2 Days, any sex, with Premature Birth. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04586608
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Iaso Maternity Hospital, Athens, Greece trials
Trials by the same sponsor.
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- NCT04876560 — Implementation of a CDSS in Oncology Patients During COVID-19 · NA · completed
- NCT06380010 — Mediterranean Diet Intervention in Adolescents With Polycystic Ovary Syndrome · NA · completed
- NCT03618394 — Bone Turnover and Parenteral Nutrition · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04586608 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Iaso Maternity Hospital, Athens, Greece
- Last refreshed: 19 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04586608.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing