Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Research Ethics Number (La Trobe University): 00/124
Study information
Scientific title
Acronym
ROBIn (Reduction of Breast Infection) Trial
Study hypothesis
The aim of our study was to prevent mastitis in breastfeeding women with cracked nipples colonised with S. aureus. The hypothesis was that a course of antibiotics would reduce mastitis in breastfeeding women with cracked nipples colonized with S. aureus. Participating women were randomised to receive a seven-day course of either an oral antibiotic (flucloxacillin) or identical placebo capsules.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mastitis (prevention of) in lactating women
Intervention
Women with nipple swab positive for Staphylococcus aureus are randomised to receive a seven-day course of:
1. Flucloxacillin 500 mg qid, or
2. Identical placebo capsules
Intervention type
Drug
Phase
Not Applicable
Drug names
Flucloxacillin
Primary outcome measures
Incidence of mastitis in each group in the week following recruitment.
Secondary outcome measures
Nipple healing, nipple pain.
Overall trial start date
01/11/2001
Overall trial end date
30/11/2002
Reason abandoned
Eligibility
Participant inclusion criteria
1. Breastfeeding women with at least one damaged nipple
2. English-speaking
3. Live in Melbourne
4. Not allergic to penicillin
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
10
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/11/2001
Recruitment end date
30/11/2002
Locations
Countries of recruitment
Australia
Trial participating centre
Director
Carlton
VIC 3053
Australia
Sponsor information
Organisation
La Trobe University (Australia)
Sponsor details
Faculty of Health Sciences
Melbourne
VIC 3086
Australia
+61 (0)3 9479 3583
lhs@latrobe.edu.au
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Foundation for Women and Babies, Melbourne (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Australian National Health and Medical Research Council Public Health scholarship (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Antibiotics provided by CSL Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
-
Results
Amir LH, Lumley J, Garland SM, A failed RCT to determine if antibiotics prevent mastitis: Cracked nipples colonized with Staphylococcus aureus: A randomized treatment trial [ISRCTN65289389]., BMC Pregnancy Childbirth, 2004, 4, 1, 19, doi: 10.1186/1471-2393-4-19.