Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by State University of New York - Upstate Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00620984
First received: February 13, 2008
Last updated: July 16, 2009
Last verified: July 2009
  Purpose

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.


Condition
Mastitis
Staphylococcus Aureus
Staphylococcal Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Staphylococcus Aureus Carrier Status in Breastfeeding Mothers and Infants and the Risk of Lactation Mastitis: A Large Prospective Study

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary objective will be to document the S. aureus carriage rate, including 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Does not have the ability to drop off the second set of cultures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620984

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Jayne R Charlamb, MD, IBCLC State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Jayne Charlamb, MD, IBCLC, SUNY Upstate Medical University
ClinicalTrials.gov Identifier: NCT00620984     History of Changes
Other Study ID Numbers: 5395
Study First Received: February 13, 2008
Last Updated: July 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
Staphylococcus aureus
Breastfeeding
Lactational Mastitis
Polymerase Chain Reaction (PCR) amplification analysis
staphyloccal infections
Staphyloccal Carrier State

Additional relevant MeSH terms:
Mastitis
Staphylococcal Infections
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 14, 2014