Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial

Importance Staphylococcus aureusis a leading cause of health care–associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates toS aureuscolonization, a well-established predisposing factor to invasiveS aureusdisease. Objective To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission ofS aureusfrom parents to neonates. Design, Setting, and Participants Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) withS aureus–colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018. Interventions 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. Main Outcomes and Measures The primary end point was concordantS aureuscolonization by 90 days, defined as neonatal acquisition of anS aureusstrain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of anyS aureusstrain and neonatalS aureusinfections. Results 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%) acquiredS aureuscolonization 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 concordantS aureuscolonization (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 anyS aureusstrain (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 anS aureusinfection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo). Conclusions and Relevance In this preliminary trial of parents colonized withS aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with anS aureusstrain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability. Trial Registration ClinicalTrials.gov Identifier:NCT02223520