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Background Atelectasis is a common complication in neonatal anesthesia. Lung ultrasound (LUS) can be used intraoperatively to evaluate and recognize atelectatic lung areas. Hypotheses for the study are: (1) The use of LUS to guide choice of best positive end-expiratory pressure ( PEEP ) can lead to reduction of FiO 2 to achieve same saturations of oxygen (SpO 2 ). (2) In a less de-recruited lung, there will be less postoperative pulmonary complications. (3) Static respiratory system compliance could be different. (4) Hemodynamic parameters and amount of fluids infused or need for vasopressors intraoperatively could be different. Methods We propose a randomized controlled trial that compares standard PEEP settings with LUS-guided PEEP choice in patients under 2 months of age undergoing general anesthesia. Results The primary aim is to determine whether LUS-guided PEEP choice in neonatal anesthesia, compared to standard PEEP choice, can lead to reduction of FiO 2 applied to the ventilatory setting in order to maintain same SpO 2 s. Secondary aims are to determine whether patients treated with LUS-guided PEEP will develop less postoperative pulmonary complications, will have a significant difference in hemodynamic parameters and amount of fluids or vasopressors infused, and in static respiratory system compliance. Conclusions We expect a significant reduction of FiO 2 in LUS-guided ventilation. Impact Lung atelectasis is extremely common in neonatal anesthesia, because of the physiology of the neonatal lung and chest wall and leads to hypoxemia, being a lung area with a perfusion/ventilation mismatch. Raising inspired fraction of oxygen can overcome temporarily hypoxemia but oxygen is a toxic compound for newborns. Lung ultrasound (LUS) can detect atelectasis at bedside and be used to optimize ventilator settings including choice of positive end-expiratory pressure (PEEP). This randomized controlled trial (RCT) aims at demonstrating that LUS-guided choice of best PEEP during neonatal anesthesia can lead to reduction of inspired fractions of oxygen to keep same peripheral saturations SpO 2 .

Introduction Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA. Methods The NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5–1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician’s discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks. Discussion The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice. Impact Pre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA). This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort. The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.

The COVID-19 pandemic has evolved into a severe psychosocial crisis affecting patients, their relatives, friends, and healthcare professionals. In Italy, public health residents (PHRs) remain essential to the national response to the pandemic. To assess their mental sphere, the “Public Mental Health” working group of the medical residents’ Assembly of the Italian Society of Hygiene and Preventive Medicine has designed the Public Health Residents’ Anonymous Survey in Italy (PHRASI). This is a nation-wide cross-sectional study based on an 88-item self-administered voluntary survey that evaluates how sociodemographic variables are associated with mental issues, including wellness, eating disorders, sleeplessness, alcohol misuse, depression, and anxiety. Data will be gathered by disseminating a Google Forms link across the Assembly network of medical residents. All PHRs enrolled in a four-year program in one of the Italian postgraduate schools of public health will be qualified as participants. PHRASI aims to draw a comprehensive and detailed picture of the mental health state of Italian PHRs. PHRs are a significant group of healthcare professionals that may serve as a future benchmark for developing and enacting regulations intended to support the mental health of healthcare professionals.

Background Newborns are at high risk of sepsis. At present there is no definitive “rule in” blood test for sepsis at the point of clinical concern. A positive blood culture remains the gold standard test for neonatal sepsis, however laboratory markers that correlate prospectively with culture positive sepsis could aid clinicians in making decisions regarding administration of empiric antibiotic therapies. Methods This multi-site, prospective observational study will take place in two neonatal intensive care units (National Maternity Hospital and Rotunda Hospital, Dublin). Neonates born at less than 34 weeks will be enroled and informed consent obtained prior to late onset sepsis work up. If at any point subsequently during their neonatal intensive care stay they develop signs and symptoms of possible sepsis requiring blood culture, an additional sodium citrate sample will be obtained. Infants will be categorised into three groups as follows: (i) culture positive sepsis, (ii) culture negative sepsis where an infant receives 5 days of antibiotics (iii) non sepsis. Our primary outcome is to establish if differential platelet/endothelial activation can prospectively identify neonatal culture positive late onset sepsis. Trial registration number NCT05530330 Impact Preterm infants are a high risk group for the development of sepsis which is a major cause of mortality in this population. Platelets have been associated with host response to invasive bacterial infections both in animal models and translational work. A positive blood culture is the gold standard test for neonatal sepsis but can be unreliable due to limited blood sampling in the very low birth weight population. This study hopes to establish if platelet/endothelial associated plasma proteins can prospectively identify late onset neonatal sepsis.

Background There is an unmet need for treatment options in intermediate age-related macular degeneration (iAMD). However, for any new interventions to be tested in clinical trials, novel currently unavailable clinical endpoints need to be developed. Thus, the MACUSTAR study aims to develop and evaluate functional, structural, and patient-reported candidate endpoints for use in future iAMD trials. Methods The protocol describes a low-interventional clinical multicenter study employing a novel two-part design. The cross-sectional part (total duration, 1 month) and the longitudinal part (total duration, 36 months) include participants with iAMD and control groups with early/late/no AMD. The cross-sectional part’s primary objective is a technical evaluation of functional, structural, and patient-reported candidate outcomes. The longitudinal part’s primary objective is to assess the prognostic power of changes in functional, structural, and patient-reported outcomes for progression from iAMD to late AMD. All data will be used to support a biomarker qualification procedure by regulatory authorities. Discussion The MACUSTAR study characterizes and evaluates much needed novel functional, structural, and patient-reported endpoints for future clinical trials in iAMD and will improve our understanding of the natural history and prognostic markers of this condition. Trial registration ClinicalTrials.gov NCT03349801 . Registered on 22 November 2017

Background Acute pancreatitis (AP) is an inflammatory disorder that causes a considerable economic health burden. While the overall mortality is low, around 20% of patients have a complicated course of disease resulting in increased morbidity and mortality. There is an emerging body of evidence that the microbiome exerts a crucial impact on the pathophysiology and course of AP. For several decades multiple clinical and laboratory parameters have been evaluated, and complex scoring systems were developed to predict the clinical course of AP upon admission. However, the majority of scoring systems are determined after several days and achieve a sensitivity around 70% for early prediction of severe AP. Thus, continued efforts are required to investigate reliable biomarkers for the early prediction of severity in order to guide early clinical management of AP patients. Methods We designed a multi-center, prospective clinical-translational study to test whether the orointestinal microbiome may serve as novel early predictor of the course, severity and outcome of patients with AP. We will recruit 400 AP patients and obtain buccal and rectal swabs within 72 h of admission to the hospital. Following DNA extraction, microbiome analysis will be performed using 3rd generation sequencing Oxford Nanopore Technologies (ONT) for 16S rRNA and metagenomic sequencing. Alpha- and beta-diversity will be determined and correlated to the revised Atlanta classification and additional clinical outcome parameters such as the length of hospital stay, number and type of complications, number of interventions and 30-day mortality. Discussion If AP patients show a distinct orointestinal microbiome dependent on the severity and course of the disease, microbiome sequencing could rapidly be implemented in the early clinical management of AP patients in the future. Trial registration : ClinicalTrials.gov Identifier: NCT04777812

Background Falls and fall-related injuries among older adults in Singapore are a serious health problem that require early intervention. In previous research, exercise interventions have been effective in improving functional outcomes and reducing falls for a broad group of older adults. However, results from multi-domain, multi-component falls prevention programs for high fall risk older adults in the community remain equivocal. One reason for these results is that there is significant heterogeneity in falls risk factors amongst high falls risk older adults which makes tailoring multicomponent interventions complex. The objective of the trial is to evaluate the effectiveness of an enhanced version of the predecessor program, SAFE. The Steps to Avoid Falls in the Elderly—a TECHnology enhanced intervention (SAFE-TECH) is designed for older adults in the community who are at high risk of falls, with candidate selection and program tailoring based on gait variables derived from wearable sensors and various questionnaire-based features. Methods SAFE-TECH is a 12-month randomized controlled trial involving 400 older adults at high risk of falling, who are randomly allocated to an intervention or control group in a 1:1 ratio. Participants will be assessed at baseline, 3rd-month and 12th-month for functional status, physical performance, cognitive status, quality of life, and medical history. Monthly phone calls will assess fall status, healthcare utilization, physical activity, and exercise self-efficacy. Participants in the intervention group will undergo a tailored, multi-domain, multi-component falls prevention program. The active intervention phase will last for 12-weeks with exercises focusing on strength, balance, coordination, flexibility, and aerobic endurance; and weekly educational sessions on falls risk with personalized feedback based on participant’s falls risk assessments and environmental checklist. Discussions SAFE-TECH seeks to evaluate enhanced existing falls prevention programs by addressing the heterogeneity of falls risk through rapid assessments and personalisation of exercise and education components while maintaining the efficiency of the group setting. Our findings will inform practical efforts to reduce falls and falls-related injuries among community-dwelling older adults. Trial registration ClinicalTrials.gov. Clinical Trial Number: NCT06102954|| 22–10-2023.

Background Thirdhand smoke (THS) is an emerging public health issue, posing risks during pregnancy, including chronic diseases, fetal harm, and cognitive-behavioral disorders in children. This study aims to design, implement, and evaluate an educational intervention to improve the awareness, beliefs, and practices of pregnant women in relation to thirdhand smoke exposure. Methods This study, conducted in 2023–2024, evaluates an educational intervention’s impact on pregnant women’s knowledge, beliefs, and practices regarding thirdhand smoke (THS) exposure. It involves 100 pregnant women from four healthcare centers in Isfahan, Iran, selected by geographic zoning and randomly assigned to intervention or control groups (50 per group) via coin toss, with 5% type I error and 80% power. Data collection uses the Beliefs About Thirdhand Smoke (BATHS) questionnaire and a researcher-designed questionnaire on THS knowledge and practices. The study has three phases: Phase 1: psychometric evaluation of questionnaires and pre-test implementation • Psychometric evaluation of questionnaires for validity and reliability: to ensure the validity and reliability of the questionnaires, two groups of pregnant women (20 participants in each group—intervention and control) will complete the questionnaires. In addition, the educational content will be evaluated by a panel of at least 10 experts using indices such as the Content Validity Index (CVI), Clarity and Simplicity Index, Attractiveness Index, and Practicality Index. • Pre-test implementation: awareness, belief, and behavior questionnaires regarding third-hand smoke exposure will be completed by pregnant women attending health centers in Isfahan, with 50 participants in each of the intervention and control groups. Phase 2: design and implementation of the educational intervention Based on the pre-test results, an educational intervention will be designed and implemented. The intervention will be conducted in group sessions, both in-person (individual and face-to-face) and virtually via online platforms. The educational content will include scientific information about the dangers of third-hand smoke, preventive strategies, and behavior change methods. Phase 3: Post-test and analysis: Post-test one month post-intervention using the same questionnaires. Data analysis with SPSS v23 includes t-tests, chi-square, Kolmogorov-Smirnov, and non-parametric tests (e.g., Mann-Whitney, Wilcoxon) for non-normal data. Trial registration: IRCT20250105064282N1 was completed on 08/04/2025. Conclusion This study examines how educational interventions can improve pregnant women’s knowledge, beliefs, and practices about thirdhand smoke (THS). Tailored education, using combined group and individual approaches, can boost awareness of THS risks and encourage protective behaviors. Social support and tobacco control policies in public spaces can further enhance these effects, especially in communities with low awareness of tobacco-related harms.

Introduction Colorectal cancer(CRC) patients are among the incurable groups who need comprehensive palliative care covering all aspects including physical, mental, social, and spiritual . The purpose of this study is to develop, implement, and evaluate a holistic palliative care program for CRC patients in order to improve quality of life of CRC patients. Methods This study is an exploratory mixed methods study which will be conducted using a sequential qualitative-quantitative design (QUAL quan) consists of four sequential steps using the approach proposed by Ewles & Sminett to develop the program. In the first phase, a qualitative study (semi-structured interview) will be conducted to discover the needs of CRC patients from the perspective of patients, family members and care providers. In the second phase, the literature review will be performed with the aim of confirming and completing the discovering new needs. In the third phase, in order to prioritize the identified needs and prepare a initial draft of the palliative care program will be done a panel of experts. In the fourth phase, the part of the developed program according to the opinions of the panel of experts, will be implemented as quasi-experimental intervention and the effect of intervention on quality of life will be evaluated. Discussion This results of this study are expected to meet the needs of CRC patients and their families through providing a holistic care and improve their quality of life in the socio-cultural context of Iran. This program can be useful in providing care, education, policy making and for future research.