Abstract
Infection in neonates remains a substantial problem. Advances for this population are hindered by the absence of a consensus definition for sepsis. In adults, the Sequential Organ Failure Assessment (SOFA) operationalizes mortality risk with infection and defines sepsis. The generalizability of the neonatal SOFA (nSOFA) for neonatal late-onset infection-related mortality remains unknown. To determine the generalizability of the nSOFA for neonatal late-onset infection-related mortality across multiple sites. A multicenter retrospective cohort study was conducted at 7 academic neonatal intensive care units between January 1, 2010, and December 31, 2019. Participants included 653 preterm (<33 weeks) very low-birth-weight infants. Late-onset (>72 hours of life) infection including bacteremia, fungemia, or surgical peritonitis. The primary outcome was late-onset infection episode mortality. The nSOFA scores from survivors and nonsurvivors with confirmed late-onset infection were compared at 9 time points (T) preceding and following event onset. In the 653 infants who met inclusion criteria, median gestational age was 25.5 weeks (interquartile range, 24-27 weeks) and median birth weight was 780 g (interquartile range, 638-960 g). A total of 366 infants (56%) were male. Late-onset infection episode mortality occurred in 97 infants (15%). Area under the receiver operating characteristic curves for mortality in the total cohort ranged across study centers from 0.71 to 0.95 (T0 hours), 0.77 to 0.96 (T6 hours), and 0.78 to 0.96 (T12 hours), with utility noted at all centers and in aggregate. Using the maximum nSOFA score at T0 or T6, the area under the receiver operating characteristic curve for mortality was 0.88 (95% CI, 0.84-0.91). Analyses stratified by sex or Gram-stain identification of pathogen class or restricted to infants born at less than 25 weeks' completed gestation did not reduce the association of the nSOFA score with infection-related mortality. The nSOFA score was associated with late-onset infection mortality in preterm infants at the time of evaluation both in aggregate and in each center. These findings suggest that the nSOFA may serve as the foundation for a consensus definition of sepsis in this population.
Highlights
Overall survival rates among preterm infants have improved, sepsis remains a significant factor associated with long-term morbidity and mortality in this population.1-4 Late-onset sepsis affects 20% to 30% of the most preterm infants and has a 15% mortality rate.5-10 Despite multiple efforts, the methods of diagnosis, clinical management, and outcomes for preterm infants with late-onset sepsis have been largely unchanged over several decades
Area under the receiver operating characteristic curves for mortality in the total cohort ranged across study centers from 0.71 to 0.95 (T0 hours), 0.77 to 0.96 (T6 hours), and 0.78 to 0.96 (T12 hours), with utility noted at all centers and in aggregate
Using the maximum neonatal SOFA (nSOFA) score at time 0 (T0) or T6, the area under the receiver operating characteristic curve for mortality was 0.88
Summary
Overall survival rates among preterm infants have improved, sepsis remains a significant factor associated with long-term morbidity and mortality in this population. Late-onset sepsis (sepsis that occurs after 72 hours of life during the birth hospitalization) affects 20% to 30% of the most preterm infants and has a 15% mortality rate. Despite multiple efforts, the methods of diagnosis, clinical management, and outcomes for preterm infants with late-onset sepsis have been largely unchanged over several decades. The methods of diagnosis, clinical management, and outcomes for preterm infants with late-onset sepsis have been largely unchanged over several decades. These findings are in part due to a lack of an accepted consensus definition for sepsis and a paucity of validated metrics reliably associated with sepsisrelated mortality in this population.. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.. A failure to incorporate the presence or severity of organ dysfunction in preterm infants with late-onset sepsis prevents grouping of patients according to severity and mortality risk, which is necessary for advancements in research and improved outcomes Definitions of sepsis used in neonatology are mostly predicated on the isolation of bacterial pathogens from blood and/or the associated length of antimicrobial treatment. A failure to incorporate the presence or severity of organ dysfunction in preterm infants with late-onset sepsis prevents grouping of patients according to severity and mortality risk, which is necessary for advancements in research and improved outcomes
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