Fewer infants colonized when parents underwent cleaning procedure.
This story was first published on Monday, December 30 in MedPage Today.
By Molly Walker, Associate Editor.
Half as many infants in the neonatal intensive care unit (NICU) became colonized with the same strain of Staphylococcus aureus as their parents when the latter underwent decolonization procedures in a randomized, placebo-controlled trial.
Rates of colonization with parents' S. aureus strain within 90 days of randomization were 14.6% in the intervention group versus 28.7% in the placebo group, reported Aaron Milstone, MD, of Johns Hopkins University in Baltimore, and colleagues.
That translated to a hazard ratio of 0.43 (95.2% CI 0.16-0.79, P=0.03), the authors wrote in a preliminary communication in JAMA.
Milstone and colleagues noted that while S. aureus is a leading cause of healthcare-associated infections among NICUs, many infection prevention strategies are generally focused on healthcare workers and the hospital environment, but that "postnatal transmission from mother to infant is common in the first few months of life."
Researchers hypothesized that if they treated S. aureus-colonized parents, with intranasal mupirocin, an antibiotic ointment designed to treat skin infections, and chlorhexidine gluconate antisepsis, a skin cleaner, it would ultimately reduce S. aureus in infants.
The Treating Parents to Reduce Neonatal Transmission of Staphylococcus aureus (TREAT PARENTS) trial enrolled eligible infants and their parents in two tertiary care NICUs from November 2014 to December 2018. Criteria for eligible infants included that they had cultured positive for S. aureus, had at least a 5-day stay, and had at least one parent who tested positive for S. aureus at screening.
Parents in the intervention group received antibiotic ointment and cloths with medicated skin cleaner, and parents in the control group received placebo ointment and cloths with non-medicated skin cleaner. They were instructed to apply the ointment twice daily in their nostrils and use the packaged cloths to clean their arms, legs, chest, neck, back, and perineum for 5 days.
The primary outcome was neonatal acquisition of an S. aureus strain concordant with the strain their parents were colonized with in baseline screening.
There were 208 infants in the analytic sample. A little over half were boys, three-quarters were singleton births, their mean birth weight was 1,985 g, and mean parent age was 31. With 18 infants lost to follow-up, 190 were included in the analysis, Milstone and colleagues said: 89 in the intervention group and 101 in the placebo group.
Fewer infants in the intervention group acquired any S. aureus colonization within 90 days of randomization versus the control group (33.7% vs 45.5%, respectively), similarly reflected when calculated as a hazard ratio (HR 0.57, 95% bias-corrected and accelerated CI 0.31-0.88). Infants in the intervention group were also linked with a lower risk of S. aureus colonization by NICU discharge and a lower risk of acquiring S. aureus colonization within 4 weeks, the authors said.
There were 26 adverse events reported by study parents, and nearly all were either mild skin irritation or nasal congestion.
Limitations to the data included that this trial enrolled in centers with "comprehensive S. aureus surveillance and decolonization programs," which could limit its generalizability, and that the definition of true adherence to the intervention may have been overestimated true adherence.
An accompanying editorial by Philip Zachariah, MD, of Columbia University Irving Medical Center, and Lisa Saiman, MD, of NewYork-Presbyterian Hospital, praised the study as "bold and innovative," and said that it "offers a novel and promising strategy to address a highly relevant, often intractable, clinical problem."
But they also listed some caveats, including that the study was not powered to detect differences in infections or mortality between groups. The editorialists noted potential issues with scalability of the results, given that the study not only took 4 years to complete, but that 93% of screened infants did not fulfill inclusion criteria.
"Cost-effectiveness will also need to be determined," Zachariah and Saiman wrote. "While the number needed to treat (NNT) to prevent S. aureus colonization may be acceptable, the much higher NNT to prevent S. aureus infection necessitates additional data derived from a much larger sample size before widespread adoption of parental decolonization could be considered."
But ultimately, the editorialists said that the future of parent screening programs such as this will be dependent "on multicenter studies that demonstrate reductions in invasive infections."
This study was supported by the Agency for Healthcare Research and Quality.
Milstone disclosed support from the CDC, the NIH, Sage Products Inc, and Becton Dickinson.
Other co-authors disclosed support from Novartis, Theravance, Basilea, the NIH, Singulex Inc, Curetis Inc, Accelerate Inc, GenMark, Pattern Diagnostics, and Becton Dickinson.
Rates of colonization with parents' S. aureus strain within 90 days of randomization were 14.6% in the intervention group versus 28.7% in the placebo group.
While S. aureus is a leading cause of healthcare-associated infections among NICUs, many infection prevention strategies focus on healthcare workers and the hospital environment.