BORN study: a multicenter randomized trial investigating cord blood red blood cell transfusions to reduce the severity of retinopathy of prematurity in extremely low gestational age neonates.

BACKGROUND: Extremely low gestational age neonates (ELGANs, i.e., neonates born before 28 weeks of gestation) are at high risk of developing retinopathy of prematurity (ROP), with potential long-life visual impairment. Due to concomitant anemia, ELGANs need repeated red blood cell (RBC) transfusions. These produce a progressive replacement of fetal hemoglobin (HbF) by adult hemoglobin (HbA). Furthermore, a close association exists between low levels of HbF and severe ROP, suggesting that a perturbation of the HbF-mediated oxygen release may derange retinal angiogenesis and promote ROP. METHODS/DESIGN: BORN (umBilical blOod to tRansfuse preterm Neonates) is a multicenter double-blinded randomized controlled trial in ELGANs, to assess the effect of allogeneic cord blood RBC transfusions (CB-RBCs) on severe ROP development. Recruitment, consent, and randomization take place at 10 neonatology intensive care units (NICUs) of 8 Italian tertiary hospitals. ELGANs with gestational age at birth comprised between 24+0 and 27+6 weeks are randomly allocated into two groups: (1) standard RBC transfusions (adult-RBCs) (control arm) and (2) CB-RBCs (intervention arm). In case of transfusion need, enrolled patients receive transfusions according to the allocation arm, unless an ABO/RhD CB-RBC is unavailable. Nine Italian public CB banks cooperate to make available a suitable amount of CB-RBC units for all participating NICUs. The primary outcome is the incidence of severe ROP (stage 3 or higher) at discharge or 40 weeks of postmenstrual age, which occurs first. DISCUSSION: BORN is a groundbreaking trial, pioneering a new transfusion approach dedicated to ELGANs at high risk for severe ROP. In previous non-randomized trials, this transfusion approach was proven feasible and able to prevent the HbF decrease in patients requiring multiple transfusions. Should the BORN trial confirm the efficacy of CB-RBCs in reducing ROP severity, this transfusion strategy would become the preferential blood product to be used in severely preterm neonates. TRIAL REGISTRATION: ClinicalTrials.gov NCT05100212. Registered on October 29, 2021.

A nudge intervention to improve hand hygiene compliance in the hospital.

Hand hygiene among professionals plays a crucial role in preventing healthcare-associated infections, yet poor compliance in hospital settings remains a lasting reason for concern. Nudge theory is an innovative approach to behavioral change first developed in economics and cognitive psychology, and recently spread and discussed in clinical medicine. To assess a combined nudge intervention (localized dispensers, visual reminders, and gain-framed posters) to promote hand hygiene compliance among hospital personnel. A quasi-experimental study including a pre-intervention phase and a post-intervention phase (9 + 9 consecutive months) with 117 professionals overall from three wards in a 350-bed general city hospital. Hand hygiene compliance was measured using direct observations by trained personnel and measurement of alcohol-based hand-rub consumption. Levels of hand hygiene compliance were low in the pre-intervention phase: 11.44% of hand hygiene opportunities prescribed were fulfilled overall. We observed a statistically significant effect of the nudge intervention with an increase to 18.71% (p < 0.001) in the post-intervention phase. Improvement was observed in all experimental settings (the three hospital wards). A statistical comparison across three subsequent periods of the post-intervention phase revealed no significant decay of the effect. An assessment of the collected data on alcohol-based hand-rub consumption indirectly confirms the main result in all experimental settings. Behavioral outcomes concerning hand hygiene in the hospital are indeed affected by contextual, nudging factors to a significant extent. If properly devised, nudging measures can provide a sustainable contribution to increase hand hygiene compliance in a hospital setting.

[The measurement of nursing workload in a sub-intensive unit with the Nine Equivalents of Nursing Manpower Scale]. / Rilevazione dei carichi di lavoro in un reparto di terapia sub-intensiva attraverso la scala Nine Equivalents of Nursing Manpower.

SUMMARY: The measurement of nursing workload in a sub-intensive unit with the Nine Equivalents of Nursing Manpower Scale. INTRODUCTION: The need to maximize the nursing manpower to patients complexity requires a careful assessment of the nursing workload. AIMS: To measure the nursing workload in a sub-intensive care unit and to assess the impact of patients isolated for multidrug resistant microorganisms (MDR) and with delirium, on the nursing workload. METHODS: From december 1 2014 to march 31 2015 the nursing workload of patients admitted to a semi intensive untit of a Turin Hospital was measured with Nine Equivalents of Nursing Manpower (NEMS) original and modified, adding 1 point score for patients isolated and with delirium (Richmond Agitation Sedation Scale). Admission and discharge times, and the activities performed in and out of the unit were registered. RESULTS: Two-hundred-thirty patients were daily assessed and no differences were observed in mean NEMS scores with the original and modified scale: december 17.3 vs 18.5; January 19.4 vs 20.2; February 19.9 vs 20.6; March 19.5 vs 20.1). mean scores did not change across shifts although on average 8 days a month the scores exceeded 21, identifiyng an excess workload and a need of a 2:1 patient/nurse ratio. The maximum workload was concentrated between 12.00 and 18.00 pm. CONCLUSIONS: The NEMS scale allows to measure the nursing workload. Apparently patients isolated and with delirium did not significantly impact on the nursing workload.

Absence of NF-kappaB activation by a new polystyrene-type adsorbent designed for hemoperfusion.

AIM: The aim of the study was to evaluate biocompatibility of anew polystyrene-type adsorbent (BetaSorb) designed for hemoperfusion, using second-level biomolecular analyses. The device has recently been developed to enhance beta2-microglobulin removal during hemodialysis. Molecular structure and chemical modifications of the surface beads of this cartridge should prevent exposure of dense hydrophobic surface sites to proteins, and avoid the major drawbacks of previous polystyrene-type adsorbent materials. METHODS: Whole blood of healthy donors was incubated in sterile minicolumns packed with BetaSorb Cuprophan, Hemophan, polysulfone and cellulose acetate. In parallel experiments, whole blood was recirculated for 180 min in a sham dialysis circuit equipped with the study sorbent or Hemophan or polysulfone. Biocompatibility was assessed by means of new biomolecular approaches focused on nuclear factor kappaB (NF-kappaB) activation (assessed by electrophoretic mobility shift assay), TNF-alpha and IL-1beta gene expression (evaluated by real-time PCR), TNF-alpha and IL-1beta production (measured by Western blot assay and ELISA), nitric oxide (NO) generation (detected by electron paramagnetic resonance), free oxygen radical production (by chemiluminescence in a biological assay) and the generation of the complement breakdown product C3d. RESULTS: In coincubation experiments, 5-min contact with any dialysis device, but BetaSorb, was enough to induce activation of NF-kappaB. The amount of TNF-alpha precursor form was found to increase after 5 min of exposure to each tested polymer, but no traces of mature forms of TNF-alpha or IL-1beta were detected in in vitro experimental conditions using healthy blood. NO and free oxygen radical generation were significantly lower in blood samples exposed to BetaSorb than in control dialysis devices. C3d levels were found to be increased with Hemophan, unaffected by polysulfone, and remarkably decreased with the BetaSorb device. In the sham hemodialysis experiments, NF-kappaB activation and C3d and NO profiles were similar to direct incubation experiments. Compared to basal levels, quantitation of TNF-alpha and IL-1beta mRNA revealed a 15- and 9-fold increase, respectively, in samples exposed to Hemophan for 180 min. CONCLUSIONS: The new BetaSorb device not only appears to be highly biocompatible, but shares properties that make it probably able to interfere with the activation of the inflammatory state.