Cracked nipples colonized with Staphylococcus aureus: a randomised treatment trial
| ISRCTN | ISRCTN65289389 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65289389 |
| Protocol serial number | Research Ethics Number (La Trobe University): 00/124 |
| Sponsor | La Trobe University (Australia) |
| Funders | Medical Research Foundation for Women and Babies, Melbourne (Australia), Australian National Health and Medical Research Council Public Health scholarship (Australia), Postgraduate grant, Faculty of Health Sciences, La Trobe University (Australia), Antibiotics provided by CSL Ltd |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Flucloxacillin |
| Primary outcome measure(s) |
Incidence of mastitis in each group in the week following recruitment. |
| Key secondary outcome measure(s) |
Nipple healing, nipple pain. |
| Completion date | 30/11/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
