Effect of Treating Parents Colonized With <i>Staphylococcus aureus</i> on Transmission to Neonates in the Intensive Care Unit
Authors: Aaron M. Milstone, Annie Voskertchian, Danielle W. Koontz, Dina F. Khamash, Tracy Ross, Susan W. Aucott, Maureen M. Gilmore, Sara E. Cosgrove, Karen C. Carroll, Elizabeth Colantuoni
Journal: JAMA (2019)

<h3>Importance</h3> <i>Staphylococcus aureus</i>is a leading cause of health care–associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to<i>S aureus</i>colonization, a well-established predisposing factor to invasive<i>S aureus</i>disease. <h3>Objective</h3> To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of<i>S aureus</i>from parents to neonates. <h3>Design, Setting, and Participants</h3> Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with<i>S aureus</i>–colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018. <h3>Interventions</h3> Parents were assigned to intranasal mupirocin and 2% chlorhexidine–impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days. <h3>Main Outcomes and Measures</h3> The primary end point was concordant<i>S aureus</i>colonization by 90 days, defined as neonatal acquisition of an<i>S aureus</i>strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any<i>S aureus</i>strain and neonatal<i>S aureus</i>infections. <h3>Results</h3> Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired<i>S aureus</i>colonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant<i>S aureus</i>colonization (risk difference, –14.1% [95% CI, –30.8% to –3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any<i>S aureus</i>strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an<i>S aureus</i>infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo). <h3>Conclusions and Relevance</h3> In this preliminary trial of parents colonized with<i>S aureus</i>, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an<i>S aureus</i>strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT02223520