Efficacy and safety of a new fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in pre term (<30 weeks) neonates – a randomised controlled trial

Completed

• Conditions: Neonatal nutrtion; Diet and Nutrition - Other diet and nutrition disorders; eonatal nutrtion

• Registration Number: ACTRN12609001017213
• Lead Sponsor: KING EDWARD MEMORIAL HOSPITAL FOR WOME

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Preterm neonates (<30 weeks) admitted in the neonatal unit at King Edward Memorial Hospital for Women and 2) Needing Parenteral Nutrition providing > 75% of energy expenditure requirements for at least 7 days

Exclusion Criteria

1) Blood culture positive sepsis (2)Unconjugated hyperbilirubinemia (requiring exchange transfusion) (3) Metabolic disorders including lactic and/or uncompensated acidosis (4) No parenteral consent (5) Administration of Intravenous lipid infusion prior to study (6) Postnatal age > 7 days

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ong Chain-Poly Uunsaturated Fatty Acid (LC-PUFA) levels in plasma and Red cell membrane analysis[Baseline and Day 8 of the study]

Secondary Outcome Measures

Name	Time	Method
Plasma F2-isoprostane level by GC/MS (Gas chrmatography/Mass spectrometry) method[Baseline and Day 8 of the study]