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Preliminary Communication
December 30, 2019

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

Author Affiliations
  • 1Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 2Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 3Department of Hospital Epidemiology and Infection Control, The Johns Hopkins Hospital, Baltimore, Maryland
  • 4Department of Pediatrics, Cooper University Health Care, Camden, New Jersey
  • 5Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland
  • 6Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 7Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 8Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 9Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
JAMA. Published online December 30, 2019. doi:10.1001/jama.2019.20785
Key Points

Question  Does treating parents with short-course intranasal mupirocin and topical chlorhexidine bathing compared with placebo reduce acquisition of Staphylococcus aureus colonization in neonates?

Findings  In this randomized clinical trial that included 190 neonates with parents colonized with S aureus, treating parents with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced the hazard of acquiring colonization with a parental S aureus strain (hazard ratio, 0.43).

Meaning  Treating colonized parents may reduce risk of S aureus transmission to neonates, but these findings are preliminary and require further research for replication and to assess generalizability.

Abstract

Importance  Staphylococcus aureus is a leading cause of health care–associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease.

Objective  To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates.

Design, Setting, and Participants  Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S 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 concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections.

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%) acquired S aureus 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 S aureus 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 S aureus 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 S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo).

Conclusions and Relevance  In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain 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

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