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

NCT00620984 | Completed

• 1 other identifier: 5395
• Study Type: observational
• Target: 557
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mastitis; Staphylococcus Aureus; Staphylococcal Infections

Keywords

Staphylococcus aureus; Breastfeeding; Lactational Mastitis; Polymerase Chain Reaction (PCR) amplification analysis; staphylococcal infections; staphylococcal Carrier State

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Culture results will be unblinded at the end of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Does not have the ability to drop off the second set of cultures.

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Mastitis; Staphylococcal Infections; Breast Feeding; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Feeding Behavior; Behavior; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jayne R Charlamb, MD, IBCLC

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: February 22, 2008
• Study Start: August 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (1)