Trial Review

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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
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
30/06/2009
Actual
14/07/2009
Date of last participant enrolment
Anticipated
Actual
19/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
40
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
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
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
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for public queries
Name 12522 0
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
[email protected]
Contact person for scientific queries
Name 3450 0
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
[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.