The results of a clinical trial conducted in Germany suggest gloves and gowns may not be needed for preventing bloodstream infections (BSIs) in newborns colonized with drug-resistant bacteria, researchers reported late last week in JAMA Network Open.
The cluster-randomized clinical trial, conducted from 2020 to 2023 in 12 German neonatal intensive care units (NICUs), aimed to evaluate whether standard hand hygiene disinfection alone is noninferior to standard hand hygiene disinfection combined with use of disposable, non-sterile gloves and long-sleeved gowns (extended barrier precautions) for routine care of preterm newborns colonized with third-generation cephalosporin-resistant gram-negative bacteria (3GCR-GNB).
The primary outcome of the study was the rate of healthcare-associated GNB BSIs in all newborns in the study. Secondary outcomes included transmission rated of 3GCR-GNB and rates of any infection.
The study authors note that while German regulators recommend use of extended barrier precautions for infants colonized with 3GCR-GNB, the strategy is time-consuming and costly, and its effectiveness unclear.
“From a sustainability perspective, the use of disposable gloves and gowns should be avoided wherever no clear clinical benefit has been demonstrated,” they wrote.
Outside of outbreaks, gloves and gowns not needed
A total of 9,731 infants were included in the study, with 4,699 cared for in the intervention cluster (standard hand hygiene) and 5,032 in the control cluster (standard hand hygiene plus barrier precautions). In the intervention cluster, 22 of 4,699 (0.5%) infants developed GNB-BSIs, compared with 25 of 5,023 (0.5%) in the control cluster, for a risk difference (RD) of –0.3%. At least one transmission with 3GCR-GNB was noted during 41 of 144 months in the intervention period, and 54 of 144 months during the control period (RD, –9.03%).
The total rate of BSI was 2.1% in neonates during the intervention period vs 2.0% during the control period (RD, 0.12%).
The researchers also found costs were higher in the control cluster. They estimate forgoing disposable gloves and gowns could save German NICUs €4 million ($4.6 million USD) annually.
“In line with the available evidence, we conclude from the BALTIC trial that the routine use of gowns and gloves in infants colonized with 3GCR-GNB is not necessary outside outbreak situations,” they wrote.