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
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
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.