MastitisNCT00620984
Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis
An observational study of Mastitis and Staphylococcus Aureus, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly associated with lactation mastitis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastitis, Staphylococcus Aureus, Staphylococcal Infections
- How many people
- 557 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: We will be enrolling 500 dyads (mother and newborn infant pairs) into the study over approximately a three year period. Mothers will be age 18 years or older.
Who may be able to join
- Mother must plan to breastfeed exclusively for at least two months
- Mother must be 18 years or older.
- Mother must speak English and capable of giving informed consent
- Must be the delivery of a term (37 weeks or more), singleton live infant.
- Mother must be within post-partum day zero to three-status post delivery
- Both mother and infant generally healthy without disease known to cause significant immune dysfunction or known to be associated with abnormally high carriage rates of S. aureus such as HIV-positive status or AIDS, Type I Diabetes Mellitus, ongoing need for hemodialysis or chronic steroid use, or receiving either chemotherapy/radiation treatment for malignancy?
- Must have the ability to communicate via phone for follow up assessments.
Who cannot join
- Does not have the ability to drop off the second set of cultures.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study
Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly associated with lactation mastitis. Twenty percent of the general population are carriers of Staphylococcus aureus, which means that they carry the infectious germ but do not become ill from it. It has been suggested that mothers who are carriers of S. aureus in their nostril may be at an increased risk of developing lactational mastitis, however; this has not been clinical proven.
We are studying the relationship between S. aureus carrier status of breastfeeding mothers and infants and the risk of developing lactational mastitis. Additionally, we are collecting questionnaire data in an attempt to better define factors predisposing women to lactation mastitis.
Read the detailed description
Lactation mastitis is an acute inflammation of the interlobular connective tissue within the mammary gland of a breastfeeding woman. It is a relatively common condition that causes pain and worry, and can lead to restriction in activity and increased risk of early weaning from breastfeeding. Staphylococcus aureus is the infectious agent most commonly implicated in lactation mastitis.
It is well established that the anterior nares are the primary reservoir of S. aureus in humans and that approximately 20% of healthy individuals are "persistent carriers" of the organism. Carriage of Staphylococcus aureus has been identified as a significant risk factor for the development of infection including surgical wound infections. It has been suggested that maternal and infant nasal carriage of S. aureus may be associated with an increased risk of breast infection during lactation.
We propose to prospectively study the relationship between the S. aureus carrier status of 500 healthy breastfeeding dyads and the rate of the subsequent development of lactational mastitis. Carrier status of mothers and infants will be determined through two nasal swabbings performed in the early post-partum period. The swabs will be analyzed with both traditional culture and through Polymerase chain reaction (PCR) amplification analysis. Mastitis rate will be determined via serial follow-up telephone interviews during the first two months post-partum.
- Conditions
- Mastitis, Staphylococcus Aureus, Staphylococcal Infections
- Keywords
- Staphylococcus aureus, Breastfeeding, Lactational Mastitis, Polymerase Chain Reaction (PCR) amplification analysis, staphylococcal infections, staphylococcal Carrier State
- Medical subject headings
- Mastitis, Staphylococcal Infections, Breast Feeding, Pathologic Complete Response
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary objective is to determine the association of nasal carriage of S. aureus in breastfeeding mothers and infants with the rate development of mastitis in the mothers.
Measured: Culture results will be unblinded at the end of the study.
Secondary outcomes (1)
Secondary objective will be to document the S. aureus carriage rate, including methicillin-resistant Staphylococcus aureus (MRSA), in early post-partum period and to assess the relationship between S. aureus carrier status of the mother and the infant.
Measured: Culture results will be unblinded at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startAug 2006
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayne Charlamb, MD, State University of New York - Upstate Medical University
- Investigators
- Jayne R Charlamb, MD, IBCLC, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620984
- Sponsor's protocol ID
- 5395
- Status last verified
- May 2015
- First submitted
- 13 Feb 2008
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study
- ClinicalTrials.gov ID
- NCT00620984
- Acronym / sponsor ID
- 5395
- Conditions
- Mastitis, Staphylococcus Aureus, Staphylococcal Infections
- Keywords
- Staphylococcus aureus, Breastfeeding, Lactational Mastitis, Polymerase Chain Reaction (PCR) amplification analysis, staphylococcal infections, staphylococcal Carrier State
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lactation (breastfeeding) mastitis is an acute infection of the milk ducts of the breastfeeding woman. Staphylococcus aureus (S. aureus) is the infectious germ most commonly associated with lactation mastitis. Twenty percent of the general population are carriers of Staphylococcus aureus, which means that they carry the infectious germ but do not become ill from it. It has been suggested that mothers who are carriers of S. aureus in their nostril may be at an increased risk of developing lactational mastitis, however; this has not been clinical proven.
We are studying the relationship between S. aureus carrier status of breastfeeding mothers and infants and the risk of developing lactational mastitis. Additionally, we are collecting questionnaire data in an attempt to better define factors predisposing women to lactation mastitis.
Detailed description
Lactation mastitis is an acute inflammation of the interlobular connective tissue within the mammary gland of a breastfeeding woman. It is a relatively common condition that causes pain and worry, and can lead to restriction in activity and increased risk of early weaning from breastfeeding. Staphylococcus aureus is the infectious agent most commonly implicated in lactation mastitis.
It is well established that the anterior nares are the primary reservoir of S. aureus in humans and that approximately 20% of healthy individuals are "persistent carriers" of the organism. Carriage of Staphylococcus aureus has been identified as a significant risk factor for the development of infection including surgical wound infections. It has been suggested that maternal and infant nasal carriage of S. aureus may be associated with an increased risk of breast infection during lactation.
We propose to prospectively study the relationship between the S. aureus carrier status of 500 healthy breastfeeding dyads and the rate of the subsequent development of lactational mastitis. Carrier status of mothers and infants will be determined through two nasal swabbings performed in the early post-partum period. The swabs will be analyzed with both traditional culture and through Polymerase chain reaction (PCR) amplification analysis. Mastitis rate will be determined via serial follow-up telephone interviews during the first two months post-partum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will be enrolling 500 dyads (mother and newborn infant pairs) into the study over approximately a three year period. Mothers will be age 18 years or older.
Key inclusion criteria (7 listed)
- Mother must plan to breastfeed exclusively for at least two months
- Mother must be 18 years or older.
- Mother must speak English and capable of giving informed consent
- Must be the delivery of a term (37 weeks or more), singleton live infant.
- Mother must be within post-partum day zero to three-status post delivery
Key exclusion criteria (1 listed)
- Does not have the ability to drop off the second set of cultures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Our primary objective is to determine the association of nasal carriage of S. aureus in breastfeeding mothers and infants with the rate development of mastitis in the mothers.
Time frame: Culture results will be unblinded at the end of the study.
1 secondary outcome
Secondary objective will be to document the S. aureus carriage rate, including methicillin-resistant Staphylococcus aureus (MRSA), in early post-partum period and to assess the relationship between S. aureus carrier status of the mother and the infant.
Time frame: Culture results will be unblinded at the end of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Mastitis
RecruitingObservational study
Ablation Versus Non-ablation Strategies for Non-puerperal Mastitis: A Prospective Real-world Registry Study
Non-Puerperal Mastitis
RecruitingObservational study
GRAnulomatous MAstitis REGistry Study
Idiopathic Granulomatous Mastitis, Granulomatous Mastitis
Recruiting
IMPACT: Improving Maternal Postpartum Access to Care Through Telemedicine
Postpartum Complication
RecruitingObservational study
Evaluation of Non-Surgical Treatment of Breast Abscess
Breast Abscess
Not yet recruitingPhase 1/2
Tocilizumab for the Treatment of Refractory Granulomatous Lobular Mastitis
Granulomatous Lobular Mastitis, Granulomatous Mastitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jayne R Charlamb, MD, IBCLC principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mastitis and Staphylococcus Aureus, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary objective is to determine the association of nasal carriage of S. aureus in breastfeeding mothers and infants with the rate development of mastitis in the mothers. (time frame: Culture results will be unblinded at the end of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.