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Trial registered on ANZCTR


Registration number
ACTRN12607000144415
Ethics application status
Approved
Date submitted
16/01/2007
Date registered
26/02/2007
Date last updated
1/06/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of probiotics to reduce the incidence of sepsis in premature infants.
Scientific title
Probiotic effects of ABC Dophilus Infant Powder on incidence, mortality and severity of sepsis in very premature neonates.
Secondary ID [1] 253268 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Late onset sepsis in very premature infants (<32 weeks) 1638 0
Condition category
Condition code
Blood 1746 1746 0 0
Other blood disorders
Reproductive Health and Childbirth 1747 1747 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a prospective double-blind placebo-controlled randomised trial investigating the effect of treatment of very low birthweight infants with a probiotic combination (ABC Dophilus Infant Powder) on the primary outcome measure, late onset sepsis. The intervetion ABC Dophilus infant powder contains 1x10^9 of total organisms, consisting of 3 bacterial strains (Bifidobacterium infantis, Bifidobacterium bifidus, Streptococcus thermophilus). This is presented in a powder form in a jar, which is opened, 0.5 teaspoon mixed with 3ml feed and given daily by mouth/nasogastric tube, from the start of milk feeds until dischared home or term (40 weeks post menstral age), whichever comes first.
Intervention code [1] 1532 0
Prevention
Comparator / control treatment
The placebo will appear identical to the probiotic and consists of maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 2433 0
The incidence of proven or probable late onset sepsis (>48 hrs after birth)
Timepoint [1] 2433 0
Before expected due date (EDD).
Primary outcome [2] 2434 0
The frequency events
Timepoint [2] 2434 0
Continuous surveillance
Primary outcome [3] 2435 0
Cummulative frequency
Timepoint [3] 2435 0
Compared at 4 weeks of age and at EDD.
Secondary outcome [1] 4201 0
The incidence of necrotising enterocolitis (NEC), death, length of the primary hospital admission including proportion experiencing prolonged hospital stay, number of courses of antibiotics, number of days until full oral feeds established (120 ml/kg).
Timepoint [1] 4201 0
These will be measured at EDD.
Secondary outcome [2] 4202 0
Weight, length and head cirucmference
Timepoint [2] 4202 0
Measured at the 6 and 12 months corrected age, and hospital admissions during the first year will be measured at 12 months corrected age.
Secondary outcome [3] 4203 0
Blood (1-2 ml) to measure immunoglobulins, number of Tregs, and IL-10 and transforming growth factor-beta (TGF-beta).
Timepoint [3] 4203 0
Will be taken at 6 and 12 months
Secondary outcome [4] 4204 0
A maternal questionnaire will be used to report atopic eczema, but will also note food allergies, and wheeze from term until 12 months corrected age.
Timepoint [4] 4204 0
At 12 months

Eligibility
Key inclusion criteria
Infants born/transferred to participating hospital within 72 hrs of birth. * the birthweight of the infant is < 1500 g and < 32 weeks gestation. *Informed written parental consent is obtained.
Minimum age
1 Days
Maximum age
3 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The infant has a known or suspected major congenital abnormality* Infants likely to die within 72 hours.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be achieved using variable block design. Randomisation will be stratified by centre and birth weight of a) <1500g and b) <1000g. Each of the participating neonatal unit will be able to access the next sequentially numbered envelope and numbered probiotic or placebo immediately after randomistation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All doctors (who assess the outcomes), nurses (who take care of the babies), research assistants and parents would be masked to the randomisation allocation. The key held by the Chief Pharmacist at the Royal Women's Hospital and the trial statistician, both of whom are independent of the investigators.
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 1895 0
Government body
Name [1] 1895 0
National Health and Medical Research Council
Address [1] 1895 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 1895 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Royal Women's Foundation Ltd
Address
55 Flemington Rd
Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 1714 0
None
Name [1] 1714 0
nil
Address [1] 1714 0
Country [1] 1714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3521 0
The Royal Women's Hospital
Ethics committee address [1] 3521 0
Ethics committee country [1] 3521 0
Australia
Date submitted for ethics approval [1] 3521 0
Approval date [1] 3521 0
12/12/2006
Ethics approval number [1] 3521 0
06/31

Summary
Brief summary
The project is a simple randomised placebo controlled trial of probiotics for very premature infants to determine whether the probiotics reduce late onset infection and associated morbidity and mortality.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27466 0
Address 27466 0
Country 27466 0
Phone 27466 0
Fax 27466 0
Email 27466 0
Contact person for public queries
Name 10721 0
Linh Ung
Address 10721 0
The Royal Women's Hospital, 20 Flemington Road, Parkville VIC 3052
Country 10721 0
Australia
Phone 10721 0
+61 3 8345 3764
Fax 10721 0
+61 3 8345 3789
Email 10721 0
linh.ung@thewomens.org.au
Contact person for scientific queries
Name 1649 0
Dr Sue Jacobs
Address 1649 0
The Roayl Women's Hospital
132 Grattan Street
Carlton VIC 3053
Country 1649 0
Australia
Phone 1649 0
+61 3 8345 2659
Fax 1649 0
+61 3 8345 3588
Email 1649 0
Sue.Jacobs@thewomens.org.au

No information has been provided regarding IPD availability
Summary results
No Results