None listed
Conditions
Brief summary
Background: Mastitis is a common inflammatory complication of lactation that may progress to infection. The onset may be insidious or sudden, and it impacts maternal wellbeing through breast pain, fever and flu like symptoms. Mastitis may progress to abscess, and potentially impacts the health of the preterm infant through reduced milk production and possible transmission of infection. Mothers of hospitalised preterm infants are at increased risk of mastitis due to a number of predisposing factors including use of a breast pump, poor health of the mother and/or infant, and exposure to pathogens within the hospital environment. Early detection and treatment of mastitis is critical to limiting its severity, with microbiological culture of milk recommended for hospital acquired cases. While an elevated milk sodium:potassium (Na:K) ratio is considered a marker of mastitis there are currently no clinical tests to confirm its onset. Mothers of hospitalised infants are typically required to access community based medical care for suspected mastitis. This can be difficult as they are typically dependent on others for transport after a caesarean birth, and insidious symptoms can be overlooked. Point of care (POC) screening of breast milk for elevated Na:K may offer a clinical tool for early detection of mastitis and therefore timely management, thus minimising the impact on the mother and infant. Objectives: To determine whether milk Na:K >1.0 ratios measured at POC are associated with mastitis in mothers of preterm infants. To determine the incidence of mastitis in a sample of mothers who are expressing milk for their hospitalised preterm infants. To determine whether acute reductions in 24-hour milk production volumes are associated with markers of mastitis. Trial Plan: An observational study of 65 mothers of preterm infants will be carried out. Breast milk Na and K concentrations will be measured at POC and Na:K calculated every second day from day 2 to day 10, and then every 3rd day until infant discharge from the neonatal nurseries of the study hospital. In the event of suspected mastitis, Na and K monitoring will occur daily from onset to 48 hours post resolution of symptoms. Microbiological cultures of milk samples will be performed on day 8, day 13 and every 6 days until infant discharge, and at the onset of mastitis. Breast symptoms and milk production volumes will be recorded at each sampling time point. Incidence of mastitis and breastfeeding outcomes will be tracked to 8 weeks postnatal
Interventions
Mastitis is an inflammatory condition of the lactating breast that may have insidious onset and can present with or without infection. It is associated with raised breast milk sodium concentrations and elevated sodium:potassium ratios. This study will examine relationships between breast milk sodium (Na) and potassium (K) concentrations and calculated Na:K ratios (as determined through bedside monitoring devices) and symptoms of mastitis in mothers of hospitalised preterm infants.
Monitoring o
Mastitis is an inflammatory condition of the lactating breast that may have insidious onset and can present with or without infection. It is associated with raised breast milk sodium concentrations and elevated sodium:potassium ratios. This study will examine relationships between breast milk sodium (Na) and potassium (K) concentrations and calculated Na:K ratios (as determined through bedside monitoring devices) and symptoms of mastitis in mothers of hospitalised preterm infants. Monitoring of breast milk Na and K concentrations and ratios, breast health and milk production will be performed on postnatal days 2, 4, 6, 8, 10 and then every 3 days until discharge / transfer from the study hospital. (The average length of stay for the study population is estimated to be 3 weeks). Microbiological testing of milk samples will be performed on days 6, 13, then every 6 days until discharge / transfer from the study hospital. In the event that a participant develops signs of mastitis, milk Na and K concentrations and ratios, breast health symptoms and milk production will be measured daily until 48 hours post resolution of symptoms. A milk sample will be collected for microbiological analysis on the day of onset of symptoms.
Sponsors
A/Prof Donna Geddes
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
English speaking mothers of preterm infants born at 29-34 weeks gestation who are expressing breast milk for their hospitalised infants.
Exclusion criteria
Mothers who require hospitalisation beyond routine postnatal care. Mothers with complex health issues that prevent regular breast expression and/or daily visiting at study hospital. Mothers that require the use of an interpreter to receive study information and provide informed consent.
Outcome results
None listed