Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001017213
Ethics application status
Approved
Date submitted
23/11/2009
Date registered
24/11/2009
Date last updated
2/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 1148 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal nutrtion 252258 0
Condition category
Condition code
Diet and Nutrition 252447 252447 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SMOFlipid intravenous lipid emulsion (soy oil, MCT(medium chain triglycerides), olive oil and fish oil based).
Dose: 1g/kg on day 1 of study, 2g/kg on day2 and 3g/kg on day3 to day 7 of study
Intervention code [1] 241590 0
Treatment: Drugs
Comparator / control treatment
Clinoleic intravenous lipid emulsion (olive oil and soy oil based) Dose: 1g/kg on day 1 of study, 2g/kg on day2 and 3g/kg on day3 to day 7 of study
Control group
Active

Outcomes
Primary outcome [1] 253319 0
Long Chain-Poly Uunsaturated Fatty Acid (LC-PUFA) levels in plasma and Red cell membrane analysis
Timepoint [1] 253319 0
Baseline and Day 8 of the study
Secondary outcome [1] 262396 0
Plasma F2-isoprostane level by GC/MS (Gas chrmatography/Mass spectrometry) method
Timepoint [1] 262396 0
Baseline and Day 8 of the study

Eligibility
Key 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
Minimum age
1 Days
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244073 0
Charities/Societies/Foundations
Name [1] 244073 0
Womens and Infant Research Foundation
Country [1] 244073 0
Australia
Primary sponsor type
Hospital
Name
KING EDWARD MEMORIAL HOSPITAL FOR WOMEN
Address
374 BAGOT ROAD
SUBIACO
WA 60008
Country
Australia
Secondary sponsor category [1] 251416 0
None
Name [1] 251416 0
Address [1] 251416 0
Country [1] 251416 0
Other collaborator category [1] 970 0
University
Name [1] 970 0
UNIVERSITY OF WESTERN AUSTRALIA
Address [1] 970 0
School of Womens and Infant Health
374 Bagot Road
Subiaco WA 6008
Country [1] 970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258169 0
KING EDWARD MEMORIAL HOSPITAL FOR WOMEN
Ethics committee address [1] 258169 0
374 BAGOT ROAD
SUBIACO
WA 6008
Ethics committee country [1] 258169 0
Australia
Date submitted for ethics approval [1] 258169 0
Approval date [1] 258169 0
Ethics approval number [1] 258169 0

Summary
Brief summary
Fat emulsions are an essential part of parenteral nutrition (PN) combining a high energy load with an essential fatty acid (EFA) intake.The primary purpose of this study is to test the safety and efficacy of new fish oil based intravenous fat emulsion (SMOFlipid) as compared to traditional olive oil based intravenous fat emulsion (Clinoleic). This study will specifically look at plasma and red cell fatty acid levels particularly Docosahexaenoic acid (DHA) which plays an important role in development and vision of newborn babies and also oxidative strss levels (F2-isoprostanes) before and after the intervention in a randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30541 0
Address 30541 0
Country 30541 0
Phone 30541 0
Fax 30541 0
Email 30541 0
Contact person for public queries
Name 13788 0
GIRISH DESHPANDE
Address 13788 0
Department of Neonatal Paediatrics,
Nepean Hospital
Derby St, Kingswood, NSW 2747.
Country 13788 0
Australia
Phone 13788 0
+61-8-93402222
Fax 13788 0
+61-8-93401262
Email 13788 0
[email protected]
Contact person for scientific queries
Name 4716 0
GIRISH DESHPANDE
Address 4716 0
Department of Neonatal Paediatrics,
Nepean Hospital
Derby St, Kingswood, NSW 2747.
Country 4716 0
Australia
Phone 4716 0
+61-8-93402222
Fax 4716 0
+61-8-93401262
Email 4716 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.