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Trial registered on ANZCTR


Trial ID
ACTRN12611000898954
Ethics application status
Approved
Date submitted
22/08/2011
Date registered
23/08/2011
Date last updated
28/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Supporting breastfeeding In Local Communities (SILC)
Scientific title
In defined Victorian Local Government Areas (LGAs) with low breastfeeding rates, are home-based breastfeeding support visits by a Maternal and Child Health Nurse (MCHN) with or without access to a community-based breastfeeding drop-in centre effective in increasing the amount of ‘any’ breastfeeding by 10% at four months of age compared to LGAs which offer standard care?
Secondary ID [1] 262274 0
Nil
Universal Trial Number (UTN)
U1111-1122-0768
Trial acronym
SILC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breastfeeding 267976 0
Condition category
Condition code
Reproductive Health and Childbirth 268107 268107 0 0
Breast feeding

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention groups. One group receives early home-based breastfeeding support by a Maternal and Child Health Nurse (MCHN). The second intervention group receives early home-based breastfeeding support by a MCHN and access to a community-based breastfeeding drop-in centre.

Participating MCHNs will have clinical experience in diagnosing and managing common breastfeeding problems: insufficient milk, perceived insufficient milk, nipple pain and damage, breast engorgement and mastitis, nipple/breast thrush, infant tongue-tie. They will assist the mother by giving advice and support, and suggesting appropriate referrals where necessary. It will be up to the allocated MCHN to determine the number and timing of support visits for each woman referred, however, it is anticipated that on average this will be two visits. It is anticipated that up to a third of women in intervention LGAs are likely to receive the home visiting intervention.

The second intervention group will also have access to a community-based breastfeeding drop-in centre. These drop-in centres will operate for the duration of the trial intervention and women can visit them as many times as they wish. The number of days and hours the drop-in centres operate will be affected by number of births in the LGA and availability of a venue.
Intervention code [1] 266664 0
Treatment: Other
Comparator / control treatment
Women in control LGAs will have access to the current breastfeeding support that is available in their communities as well as by telephone outside their communities. This includes usual breastfeeding support provided by MCHNs (encompassing breastfeeding assessment, support and advice as a core component of care); the 24 hour Maternal Child Health line; the 24 hour Australian Breastfeeding Association helpline; and support by general practitioners and other health professionals as usual.
Control group
Active

Outcomes
Primary outcome [1] 266890 0
The proportion of infants receiving 'any' breast milk at four months of age. Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health (MCH) centre data. For the period of the study, a new data item will be added to collect information on infant feeding 'in the last 24 hours'. This data item will be collected at the routine MCHN appointment when infants are four months of age.
Timepoint [1] 266890 0
Four months postpartum
Secondary outcome [1] 276572 0
The proportion of infants receiving 'any' breast milk at six months of age. Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health (MCH) centre data. Information will also be obtained via a postal survey to women who give birth during the intervention time-frame in the participating LGAs when their infants are six months of age.
Timepoint [1] 276572 0
Six months postpartum

Eligibility
Key inclusion criteria
- LGAs with a low breastfeeding rate for ‘any’ breastfeeding at discharge from hospital

- LGAs who agree to participate and be randomised
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- LGAs with substantial initiatives (at the time of LGA selection) to increase breastfeeding duration or other substantial early childhood interventions

- LGAs where participation is not feasible given the low number of births

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)
The trial uses a three-arm cluster randomised controlled trial (RCT) design. The unit of randomisation will be the LGA. Eligible LGAs will be randomly allocated to one of three trial arms: standard care; home-based breastfeeding support by a MCHN; or home-based breastfeeding support by a MCHN plus access to a community-based breastfeeding drop-in centre.

Allocation to trial arms is concealed and will take place at a public forum to which representatives from participating LGAs will be invited. During this forum, allocation to the trial arms will be achieved using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible LGAs will be randomly allocated to one of the three trial arms; stratified by metropolitan/rural status. A computer generated randomisation program will be used to conduct the randomisation, administered by an independent statistician. LGAs allocated to the intervention arms will implement the interventions.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
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
Current
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267185 0
Government body
Name [1] 267185 0
Department of Education and Early Childhood Development
Address [1] 267185 0
2 Treasury Place
East Melbourne
VIC 3002
Country [1] 267185 0
Australia
Primary sponsor type
University
Name
Mother & Child Health Research, La Trobe University
Address
Mother & Child Health Research
La Trobe University
Level 3
215 Franklin St
Melbourne
VIC 3000
Country
Australia
Secondary sponsor category [1] 266259 0
Government body
Name [1] 266259 0
Department of Education and Early Childhood Development
Address [1] 266259 0
2 Treasury Place
East Melbourne
VIC 3002
Country [1] 266259 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269188 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 269188 0
La Trobe University
Bundoora
VIC 3086
Ethics committee country [1] 269188 0
Australia
Date submitted for ethics approval [1] 269188 0
01/09/2011
Approval date [1] 269188 0
07/11/2011
Ethics approval number [1] 269188 0
Ethics committee name [2] 269189 0
Department of Education and Early Childhood Development
Ethics committee address [2] 269189 0
2 Treasury Place
East Melbourne
VIC 3002
Ethics committee country [2] 269189 0
Australia
Date submitted for ethics approval [2] 269189 0
01/09/2011
Approval date [2] 269189 0
26/10/2011
Ethics approval number [2] 269189 0

Summary
Brief summary
The Victorian Government’s commitment to improving breastfeeding rates includes the development of the Victorian Breastfeeding Action Plan. The Victorian Breastfeeding Research Project (SILC project ) is part of this action plan.

The SILC project will assess strategies to increase the maintenance of breastfeeding. The research will consist of a three arm cluster randomised control trial. It will determine if home visiting by a Maternal and Child Health Nurse (MCHN) for women with breastfeeding issues increases the maintenance of breastfeeding, and then if a drop-in centre additional to the home-visiting further enhances breastfeeding rates.

The three arms of the trial will consist of a comparison (control) group receiving standard care, a targeted home-visiting group receiving home-based breastfeeding support visits by a MCHN and the third group receiving the targeted home visits plus access to a facilitated local drop-in centre.
Trial website
Trial related presentations / publications
Amir, LH et al. Breastfeeding in Victoria: A Report. http://www.eduweb.vic.gov.au/edulibrary/public/stuman/wellbeing/breastfeeding_vic_report.pdf
Public notes

Contacts
Principal investigator
Name 32637 0
A/Prof Helen McLachlan
Address 32637 0
Mother & Child Health Research Level 3 215 Franklin St La Trobe University Melbourne VIC 3000
Country 32637 0
Australia
Phone 32637 0
+61 3 9479 8788
Fax 32637 0
Email 32637 0
h.mclachlan@latrobe.edu.au
Contact person for public queries
Name 15884 0
Dr Meabh Cullinane
Address 15884 0
Mother & Child Health Research
Level 3
215 Franklin St
La Trobe University
Melbourne
VIC 3000
Country 15884 0
Australia
Phone 15884 0
+61 3 9479 8778
Fax 15884 0
+61 3 9479 8811
Email 15884 0
m.cullinane@latrobe.edu.au
Contact person for scientific queries
Name 6812 0
A/Prof Helen McLachlan
Address 6812 0
Mother & Child Health Research
Level 3
215 Franklin St
La Trobe University
Melbourne
VIC 3000
Country 6812 0
Australia
Phone 6812 0
+61 3 9479 8788
Fax 6812 0
+61 3 9479 8811
Email 6812 0
h.mclachlan@latrobe.edu.au