Comparison of “IN-REC-SUR-E” and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)

Background: Surfactant is a well-established therapy for preterm neonates affected by respiratory distress syndrome (RDS). The goals of different methods of surfactant administration are to reduce the duration of mechanical ventilation and the severity of bronchopulmonary dysplasia (BPD); however, the optimal administration method remains unknown. This study compares the effectiveness of the INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) technique with the less-invasive surfactant administration (LISA) technique, in increasing BPD-free survival of preterm infants. This is an international unblinded multicenter randomized controlled study in which preterm infants will be randomized into two groups to receive IN-REC-SUR-E or LISA surfactant administration. Methods: In this study, 382 infants born at 24+0–27+6 weeks’ gestation, not intubated in the delivery room and failing nasal continuous positive airway pressure (nCPAP) or nasal intermittent positive pressure ventilation (NIPPV) during the first 24 h of life, will be randomized 1:1 to receive IN-REC-SUR-E or LISA surfactant administration. The primary outcome is a composite outcome of death or BPD at 36 weeks’ postmenstrual age. The secondary outcomes are BPD at 36 weeks’ postmenstrual age; death; pulse oximetry/fraction of inspired oxygen; severe intraventricular hemorrhage; pneumothorax; duration of respiratory support and oxygen therapy; pulmonary hemorrhage; patent ductus arteriosus undergoing treatment; percentage of infants receiving more doses of surfactant; periventricular leukomalacia, severe retinopathy of prematurity, necrotizing enterocolitis, sepsis; total in-hospital stay; systemic postnatal steroids; neurodevelopmental outcomes; and respiratory function testing at 24 months of age. Randomization will be centrally provided using both stratification and permuted blocks with random block sizes and block order. Stratification factors will include center and gestational age (24+0 to 25+6 weeks or 26+0 to 27+6 weeks). Analyses will be conducted in both intention-to-treat and per-protocol populations, utilizing a log-binomial regression model that corrects for stratification factors to estimate the adjusted relative risk (RR). Discussion: This trial is designed to provide robust data on the best method of surfactant administration in spontaneously breathing preterm infants born at 24+0–27+6 weeks’ gestation affected by RDS and failing nCPAP or NIPPV during the first 24 h of life, comparing IN-REC-SUR-E to LISA technique, in increasing BPD-free survival at 36 weeks’ postmenstrual age of life. Trial registration: ClinicalTrials.gov NCT05711966. Registered on February 3, 2023

A Model-driven Approach for the Formal Analysis of Human-Robot Interaction Scenarios

Robots are currently mostly found in industrial settings. In the future, a wider range of environments will benefit from their inclusion. This calls for the development of tools that allow professionals to set up dependable robotic applications in which people productively interact with robots aware of their needs. Given the co-existence of humans and robots, the precise analysis—e.g., through formal verification techniques—of properties related to aspects such as human needs and physiology is of paramount importance. In this paper, we present a formally-based, model-driven approach to design and verify scenarios involving human-robot interactions. Some of the features of our approach are tailored to the healthcare domain, from which our case studies are derived. In our approach, the designer specifies the main parameters of the mission to generate the model of the application, which includes mobile robots, the humans to be served, including some of their physiological features, and the decision-maker that orchestrates the execution. All components are modeled through hybrid automata to capture variables with complex dynamics. The model is verified through Statistical Model Checking (SMC), using the Uppaal tool, to determine the probability of success of the mission. The results are examined by the developer, who iteratively refines the design until the probability of success is satisfactory

Experimental Seismic Test of Fluid Coupled Co-Axial Cylinders

The dynamic response of fluid coupled coaxial cylindrical shells is of interest to the nuclear industry with respect to the seismic design of the reactor vessel and thermal liner. The experiments described present a series of tests which investigate the effect of the annular clearance between the cylinders (gap) on natural frequency, damping, and seismic response of both the inner and outer cylinders. The seismic input is a time history base load to the flexible fluid filled coaxial cylinders. The outer cylinder is elastically supported at both ends while the inner cylinder is supported only at the base (lower) end