Creating and implementing an evidence-based prevention bundle to reduce late-onset sepsis in extremely low birth weight newborns: a multicenter interrupted time series study

Abstract

Background: Late-onset sepsis results in significant mortality, morbidity and prolonged length of stay in already vulnerable extremely low birth weight newborns. Neonates admitted to the Neonatal Intensive Care Unit are at high risk of acquiring healthcare-associated infections because of the immaturity of their immune system and prolonged use of invasive medical procedures and devices. Bundles are a small set of evidence-based preventive strategies that when implemented simultaneously result in additional improvements in patient outcomes, than when implemented individually. Hypotheses and Objective: This study aims to assess the efficacy of an infection prevention bundle in reducing late-onset sepsis incidence in extremely low birth weight newborns (<1.000g). Mortality and length-of-stay will also be evaluated. Design and setting: We will perform a multicenter interrupted time series study among 8 participating Spanish Neonatal Intensive Care Units. Hospital Universitari Dr. Josep Trueta will be the reference center. Intervention: All participating units will implement a self-designed prevention bundle focusing on: re-enforcement of hand hygiene, promotion of early enteral trophic feeding and specific antimicrobial stewardship strategies. Methods: Extremely low birth weight neonates with ≥72 hours of life (n=547) will be included. Outcomes (late-onset sepsis incidence, mortality and related length of stay) will be collected monthly before (pre-intervention) and after (post-intervention) the implementation of our tailored bundle. Data will be analyzed by using statistical process control methods. Expected results: We hypothesized that consistent implementation of the evidence-based bundle would result in a 20% reduction in late-onset sepsis