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Managing neonatal sepsis is challenging due to nonspecific clinical signs, hematological markers with poor accuracy, and a lengthy turnaround time for the identification of microorganisms. Delaying the initiation of antibiotics in truly infected infants can lead to severe morbidity and mortality. Therefore, decisions regarding empiric antibiotic treatment are risk stratified, which exposes many uninfected infants to antibiotics. This causes gut microbiota perturbation, unnecessary hospital admissions, and the generation of multi-resistant organisms. High-speed diagnostic assays could expedite discontinuation or avert the initiation of antibiotics in uninfected infants. This study will evaluate the diagnostic performance of molecular culture (MC), a rapid broad-range PCR-based bacterial profiling technique, for diagnosing neonatal sepsis in infants below 90 days old. A multi-center prospective observational cohort study will include infants evaluated for early and late-onset sepsis. Routine evaluation for suspected sepsis includes microbiological cultures of blood. Additionally, blood for MC will be collected. For early-onset sepsis, umbilical cord blood may be used alternatively. Primary outcome is the agreement between MC and conventional blood culture results. Secondary outcome is the agreement of both assays with clinical sepsis using four different, commonly used definitions. Faster diagnostic pathways for sepsis may reduce antibiotic exposure time. Broad-range molecular assays may identify pathogens undetectable by conventional methods. Employment of umbilical cord blood samples for early-onset sepsis diagnosis can resolve challenges in collecting adequate blood volume and could further expedite treatment decisions.

Early diagnosis and treatment of late-onset sepsis (LOS) is crucial for survival, but challenging. Intestinal microbiota and metabolome alterations precede the clinical onset of LOS, and the preterm gut is considered an important source of bacterial pathogens. Fecal volatile organic compounds (VOCs), formed by physiologic and pathophysiologic metabolic processes in the preterm gut, reflect a complex interplay between the human host, the environment, and microbiota. Disease-associated fecal VOCs can be detected with an array of devices with various potential for the development of a point-of-care test (POCT) for preclinical LOS detection. While characteristic VOCs for common LOS pathogens have been described, their VOC profiles often overlap with other pathogens due to similarities in metabolic pathways, hampering the construction of species-specific profiles. Clinical studies have, however, successfully discriminated LOS patients from healthy individuals using fecal VOC analysis with the highest predictive value for Gram-negative pathogens. This review discusses the current advancements in the development of a non-invasive fecal VOC-based POCT for early diagnosis of LOS, which may potentially provide opportunities for early intervention and targeted treatment and could improve clinical neonatal outcomes. Identification of confounding variables impacting VOC synthesis, selection of an optimal detection device, and development of standardized sampling protocols will allow for the development of a novel POCT in the near future.

Aim: The aim of our study was to investigate skin conditions when wearing and removing a novel wireless non-adhesive cardiorespiratory monitoring device for neonates (Bambi-Belt) compared to standard adhesive electrodes. Study Design: This was a prospective study including preterm neonates requiring cardiorespiratory monitoring. Besides standard electrodes, the infants wore a Bambi Belt for 10 consecutive days. Their skin conditions were assessed using Trans Epidermal Water Loss (TEWL) and the Neonatal Skin Condition Score (NSCS) after daily belt and standard electrode removal. The ∆TEWL was calculated as the difference between the TEWL at the device’s location (Bambi-Belt/standard electrode) and the adjacent control skin location, with a higher ∆TEWL indicating skin damage. Results: A total of 15 infants (gestational age (GA): 24.1–35.6 wk) were analyzed. The ΔTEWL significantly increased directly after electrode removal (10.95 ± 9.98 g/m2/h) compared to belt removal (5.18 ± 6.71 g/m2/h; F: 8.73, p = 0.004) and after the washout period (3.72 ± 5.46 g/m2/h vs. 1.86 ± 3.35 g/m2/h; F: 2.84, p = 0.09), although the latter did not reach statistical significance. The TEWL was not influenced by prolonged belt wearing. No significant differences in the NSCS score were found between the belt and electrode (OR: 0.69, 95% CI [0.17, 2.88], p = 0.6). Conclusion: A new wireless non-adhesive device for neonatal cardiorespiratory monitoring was well tolerated in preterm infants and may be less damaging during prolonged wearing.