David A Kaufman1, Amy Blackman1, Mark R Conaway2, Robert A Sinkin1. 1. Division of Neonatology, Department of Pediatrics, University of Virginia School of Medicine, Charlottesville. 2. Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville.
Abstract
IMPORTANCE: Late-onset infections commonly occur in extremely preterm infants and are associated with high rates of mortality and neurodevelopmental impairment. Hand hygiene alone does not always achieve the desired clean hands, as microorganisms are still present more than 50% of the time. We hypothesize that glove use after hand hygiene may further decrease these infections. OBJECTIVE: To determine if nonsterile glove use after hand hygiene before all patient and intravenous catheter contact, compared with hand hygiene alone, prevents late-onset infections in preterm infants. DESIGN, SETTINGS, AND PARTICIPANTS: A prospective, single-center, clinical, randomized trial was conducted in infants admitted to the neonatal intensive care unit who weighed less than 1000 g and/or had a gestational age of less than 29 weeks and were less than 8 days old. There were 175 eligible infants, of which 120 were enrolled during a 30-month period from December 8, 2008, to June 20, 2011. INTERVENTIONS: Infants were randomly assigned to receive care with nonsterile gloves after hand hygiene (group A) or care after hand hygiene alone (group B) before all patient and intravenous line (central and peripheral) contact. Study intervention was continued while patients had central or peripheral venous access. MAIN OUTCOMES AND MEASURES: One or more episodes of late-onset (>72 hours of age) infection in the bloodstream, urinary tract, or cerebrospinal fluid or necrotizing enterocolitis. RESULTS: The 2 groups were similar in baseline demographic characteristics. Late-onset invasive infection or necrotizing enterocolitis occurred in 32% of infants (19 of 60) in group A compared with 45% of infants (27 of 60) in group B (difference, -12%; 95% CI, -28% to 6%; P = .13). In group A compared with group B, there were 53% fewer gram-positive bloodstream infections (15% [9 of 60] vs 32% [19 of 60]; difference, -17%; 95% CI, -31% to -1%; P = .03) and 64% fewer central line-associated bloodstream infections (3.4 vs 9.4 per 1000 central line days; ratio, 0.36; 95% CI, 0.16 to 0.81; P = .01). CONCLUSIONS AND RELEVANCE: Glove use after hand hygiene prior to patient and line contact is associated with fewer gram-positive bloodstream infections and possible central line-associated bloodstream infections in preterm infants. This readily implementable infection control measure may result in decreased infections in high-risk preterm infants. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01729000.
RCT Entities:
IMPORTANCE: Late-onset infections commonly occur in extremely preterm infants and are associated with high rates of mortality and neurodevelopmental impairment. Hand hygiene alone does not always achieve the desired clean hands, as microorganisms are still present more than 50% of the time. We hypothesize that glove use after hand hygiene may further decrease these infections. OBJECTIVE: To determine if nonsterile glove use after hand hygiene before all patient and intravenous catheter contact, compared with hand hygiene alone, prevents late-onset infections in preterm infants. DESIGN, SETTINGS, AND PARTICIPANTS: A prospective, single-center, clinical, randomized trial was conducted in infants admitted to the neonatal intensive care unit who weighed less than 1000 g and/or had a gestational age of less than 29 weeks and were less than 8 days old. There were 175 eligible infants, of which 120 were enrolled during a 30-month period from December 8, 2008, to June 20, 2011. INTERVENTIONS:Infants were randomly assigned to receive care with nonsterile gloves after hand hygiene (group A) or care after hand hygiene alone (group B) before all patient and intravenous line (central and peripheral) contact. Study intervention was continued while patients had central or peripheral venous access. MAIN OUTCOMES AND MEASURES: One or more episodes of late-onset (>72 hours of age) infection in the bloodstream, urinary tract, or cerebrospinal fluid or necrotizing enterocolitis. RESULTS: The 2 groups were similar in baseline demographic characteristics. Late-onset invasive infection or necrotizing enterocolitis occurred in 32% of infants (19 of 60) in group A compared with 45% of infants (27 of 60) in group B (difference, -12%; 95% CI, -28% to 6%; P = .13). In group A compared with group B, there were 53% fewer gram-positive bloodstream infections (15% [9 of 60] vs 32% [19 of 60]; difference, -17%; 95% CI, -31% to -1%; P = .03) and 64% fewer central line-associated bloodstream infections (3.4 vs 9.4 per 1000 central line days; ratio, 0.36; 95% CI, 0.16 to 0.81; P = .01). CONCLUSIONS AND RELEVANCE: Glove use after hand hygiene prior to patient and line contact is associated with fewer gram-positive bloodstream infections and possible central line-associated bloodstream infections in preterm infants. This readily implementable infection control measure may result in decreased infections in high-risk preterm infants. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01729000.
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