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Trial registered on ANZCTR


Registration number
ACTRN12609000337279
Ethics application status
Approved
Date submitted
11/02/2009
Date registered
22/05/2009
Date last updated
5/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near-term (>34 weeks) neonates – a randomised controlled trial
Scientific title
Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near-term (>34 weeks) neonates – a randomised controlled trial
Secondary ID [1] 286115 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal nutrition 4315 0
Condition category
Condition code
Diet and Nutrition 4549 4549 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 4869 4869 0 0
Childbirth and postnatal care

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] 4045 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] 5427 0
Long Chain-Poly Uunsaturated Fatty Acid (LC-PUFA) levels in plasma and Red cell membrane analysis
Timepoint [1] 5427 0
Baseline and Day 8 of the study
Primary outcome [2] 5428 0
Plasma and Urinary F2-isoprostane level by GC/MS (Gas chrmatography/Mass spectrometry) method
Timepoint [2] 5428 0
Baseline and day 8 of the study
Secondary outcome [1] 9122 0
Phagocyte activation assay and cytokine production
Timepoint [1] 9122 0
Baseline and Day 8 of the study by pHRhodo assay and Enzyme-linked immunosorbent assay (ELISA)

Eligibility
Key inclusion criteria
1) Term and near term neonates (>34 weeks) admitted in the neonatal unit at Princess Margaret Hospital and 2) Needing Parenteral Nutrition providing > 75% of energy expenditure requirements for at least 7 days
Minimum age
1 Days
Maximum age
7 Days
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4485 0
Commercial sector/Industry
Name [1] 4485 0
Pharmatel Fresenius Kabi Pty Ltd
Address [1] 4485 0
964 Pacific Highway Pymble
NSW 2073 Australia
Country [1] 4485 0
Australia
Funding source category [2] 4486 0
Charities/Societies/Foundations
Name [2] 4486 0
The channel7 telethon trust at Princess Margaret Hospital for Children
Address [2] 4486 0
Roberts Road Subiaco
WA 6008
Country [2] 4486 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospsital for Children
Address
Robert's Road Subiaco
WA 6008
Country
Australia
Secondary sponsor category [1] 4300 0
None
Name [1] 4300 0
Address [1] 4300 0
Country [1] 4300 0
Other collaborator category [1] 638 0
University
Name [1] 638 0
University of Western Australia
Address [1] 638 0
School of Womens and Infant Health
374 Bagot Road Subiaco
WA 6008
Country [1] 638 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6547 0
Princess Margaret Hospital ethics committee
Ethics committee address [1] 6547 0
GPO Box D184
Perth WA 6840
Ethics committee country [1] 6547 0
Australia
Date submitted for ethics approval [1] 6547 0
Approval date [1] 6547 0
17/12/2008
Ethics approval number [1] 6547 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

1) Pediatric Academic society (PAS) meeting at Washington DC, 2013 May 4-7
2) Perinatal Society of Australia and New Zealand (PSANZ) meeting at Sydney, 2013 April 6-9
Abstract: Deshapnde G et al, Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoleic) in term and near term surgical neonates (>34 Weeks) – a randomised controlled trial
Journal of Paediatrics and Child Health;2013; 49 (Suppl. 2),42
Public notes

Contacts
Principal investigator
Name 29275 0
Dr Girish Deshpande
Address 29275 0
Nepean Hospital, Department of Neonatal Intensive Care Unit (NICU), Derby St, Kingswood,
NSW 2747, Australia
Country 29275 0
Australia
Phone 29275 0
+61247342121
Fax 29275 0
Email 29275 0
girish.deshpande@health.nsw.gov.au
Contact person for public queries
Name 12522 0
Dr Dr Girish Deshpande
Address 12522 0
Nepean Hospital, Department of Neonatal Intensive Care Unit (NICU), Derby St, Kingswood,
NSW 2747, Australia
Country 12522 0
Australia
Phone 12522 0
+61247342121
Fax 12522 0
Email 12522 0
girish.deshpande@health.nsw.gov.au
Contact person for scientific queries
Name 3450 0
Dr Dr Girish Deshpande
Address 3450 0
Nepean Hospital, Department of Neonatal Intensive Care Unit (NICU), Derby St, Kingswood,
NSW 2747, Australia
Country 3450 0
Australia
Phone 3450 0
+61247342121
Fax 3450 0
Email 3450 0
girish.deshpande@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary