Cracked nipples colonized with Staphylococcus aureus: a randomised treatment trial
| ISRCTN | ISRCTN65289389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65289389 |
| Secondary identifying numbers | Research Ethics Number (La Trobe University): 00/124 |
- Submission date
- 09/12/2002
- Registration date
- 09/12/2002
- Last edited
- 13/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Judith Lumley
Scientific
Scientific
Director
Centre for the Study of Mothers' and Children's Health
La Trobe University
251 Faraday Street
Carlton
VIC 3053
Australia
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ROBIn (Reduction of Breast Infection) Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Flucloxacillin |
| Primary outcome measure | Incidence of mastitis in each group in the week following recruitment. |
| Secondary outcome measures | Nipple healing, nipple pain. |
| Overall study start date | 01/11/2001 |
| Completion date | 30/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 10 |
| Key inclusion criteria | 1. Breastfeeding women with at least one damaged nipple 2. English-speaking 3. Live in Melbourne 4. Not allergic to penicillin |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 30/11/2002 |
Locations
Countries of recruitment
- Australia
Study participating centre
Director
Carlton
VIC 3053
Australia
VIC 3053
Australia
Sponsor information
La Trobe University (Australia)
University/education
University/education
Faculty of Health Sciences
Melbourne
VIC 3086
Australia
| Phone | +61 (0)3 9479 3583 |
|---|---|
| lhs@latrobe.edu.au | |
| Website | http://www.latrobe.edu.au/health/healthsci_schoolcent.html |
"ROR" |
https://ror.org/01rxfrp27 |
Funders
Funder type
Research council
Medical Research Foundation for Women and Babies, Melbourne (Australia)
No information available
Australian National Health and Medical Research Council Public Health scholarship (Australia)
No information available
Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia)
No information available
Antibiotics provided by CSL Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 16/09/2004 | Yes | No |
