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Background ‘Neonatal encephalopathy’ (NE) describes a group of conditions in term infants presenting in the earliest days after birth with disturbed neurological function of cerebral origin. NE is aetiologically heterogenous; one cause is peripartum hypoxic ischaemia. Lack of uniformity in the terminology used to describe NE and its diagnostic criteria creates difficulty in the design and interpretation of research and complicates communication with families. The DEFINE study aims to use a modified Delphi approach to form a consensus definition for NE, and diagnostic criteria. Methods Directed by an international steering group, we will conduct a systematic review of the literature to assess the terminology used in trials of NE, and with their guidance perform an online Real-time Delphi survey to develop a consensus diagnosis and criteria for NE. A consensus meeting will be held to agree on the final terminology and criteria, and the outcome disseminated widely. Discussion A clear and consistent consensus-based definition of NE and criteria for its diagnosis, achieved by use of a modified Delphi technique, will enable more comparability of research results and improved communication among professionals and with families. Impact The terms Neonatal Encephalopathy and Hypoxic Ischaemic Encephalopathy tend to be used interchangeably in the literature to describe a term newborn with signs of encephalopathy at birth. This creates difficulty in communication with families and carers, and between medical professionals and researchers, as well as creating difficulty with performance of research. The DEFINE project will use a Real-time Delphi approach to create a consensus definition for the term ‘Neonatal Encephalopathy’. A definition formed by this consensus approach will be accepted and utilised by the neonatal community to improve research, outcomes, and parental experience.

Background Children’s physical activity and screen time behaviours impact their physical health and well-being. In Australia, less than half of children meet daily physical activity recommendations and only one-third meet daily screen time recommendations. Nearly half a million Australian school children aged 5-12 attend Outside School Hours Care (OSHC) weekly, activities undertaken at OSHC play a key role in meeting these recommendations. Currently, physical activity and screen time practices in OSHC vary and lack policy guidance. The Activated OSHC program is a policy-based intervention that supports OSHC services to implement the physical activity and screen time guidelines. Methods 192 OSHC services across Australia will be recruited. 96 services will be randomly allocated to receive the Activated OSHC program. OSHC coordinators will complete online surveys examining physical activity and screen time scheduling, cost, acceptability, and feasibility. Primary outcome; changes in the proportion of intervention and control services meeting OSHC sector physical activity and screen time guidelines, and secondary outcomes; changes in children’s physical activity and screen time behaviours; changes in staff behaviour will be assessed using mixed-effects regression models. Discussion The aim of this study is to examine the impact of the Activated OSHC program on children’s physical activity and screen time. Impact Recent Australian research in Outside School Hours Care (OSHC) has identified significant inconsistency in practices related to physical activity and screen time, compounded by an absence of explicit policy guidance. The Activated OSHC program is a policy-based intervention that supports OSHC services to implement the Australian OSHC physical activity and screen time guidelines. This study will assess the implementation and effectiveness of the Activated OSHC program in an effectiveness-implementation hybrid type 2 trial design. Implementation of outside school hours care sector physical activity and screen time guidelines may improve children’s physical activity and screen time behaviours.

Background During puberty, lung function of individuals born extremely prematurely can deteriorate putting them at risk of early chronic obstructive pulmonary disease (COPD). We hypothesise that young adults exposed to postnatal corticosteroids will have poorer lung and cardiac function, higher pulmonary artery pressures and poorer exercise tolerance compared to preterm born adults not exposed to postnatal steroids and term born adults. We further hypothesise lung function differences may be demonstrated depending on mode of ventilation at birth (high frequency oscillatory or conventional ventilation) in preterm born adults. Methods A prospective study of participants (aged 24-28) from the United Kingdom Oscillation Study (UKOS) and term born controls. Assessments will involve comprehensive lung function, cardiac ultrasound, exercise assessments, inflammatory cell and biomarker profiling and airway microbiome assessment. The primary outcome is the ratio of forced expiratory volume in 1 s/forced vital capacity (FEV 1 /FVC); to detect a significant difference we will recruit 150 individuals. Statistical analysis will involve mixed effect models with adjustment for imbalances and sensitivity analysis. Discussion The results may identify adults born extremely preterm at increased risk of COPD and pulmonary hypertension (PH) who might benefit from interventions to delay the onset of COPD and cardiovascular complications such as PH. Impact Adults born extremely prematurely in the modern era of neonatal care are an emerging population whose long-term outcomes have infrequently been reported. This study will describe their cardiac and lung function, pulmonary artery pressures, exercise capacity and immunobiological profile. We aim to identify risk factors for worse outcomes such as early chronic obstructive pulmonary disease onset and pulmonary hypertension. The results will identify those who might benefit from multi-disciplinary follow-up to ensure interventions are employed to delay the onset of COPD and manage longer term cardiovascular problems.

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.

Background Up to 25–35% of women receive antibiotics (ABX) during pregnancy, but little is known about the consequences on a key mucosal interface such as the mammary gland, and on the development of the neonatal gut’s microbiota and IgA. We hypothesize that prenatal ABX negatively affect the immune functionality of mammary gland, the composition of breast milk microbiota, the development of neonatal fecal microbiota and the abundance of neonatal fecal IgA. Methods Case-control translational cohort study on women and neonates in the presence or absence ( N  = 41 + 41 pairs) of exposure to prenatal ABX for at least 7 consecutive days after 32 weeks of gestation. Results We will evaluate IgA concentration in breast milk and in neonatal feces up to one year after delivery. We will also evaluate clinical parameters, neurodevelopment and the composition of the IgA-coated and uncoated fractions of breast milk and fecal microbiota by means of magnetic-activated cell sorting (MACS) coupled with shotgun metagenomics. Finally, we will measure the concentration of the chemokine CCL28 on maternal serum and breast milk, as a marker of activity of the entero-mammary pathway. Conclusions Our results might support a data-driven evaluation of breast milk immune function in women exposed to prenatal ABX. Impact Breast milk IgA and microbiota are critical to determine the positive effects of breastfeeding in infants. This research protocol will investigate breast milk IgA, microbiota, and the IgA + / IgA − fractions of neonatal fecal microbiota upon exposure to prenatal antibiotics. Fecal IgA and microbiota in infants exposed or not exposed to prenatal antibiotics will be analyzed up to 1 year after birth. This research will clarify the impact of prenatal antibiotics on the immune function of breast milk. This, in turn, might support the selective evaluation of breast milk IgA/microbiota in mothers exposed to prenatal antibiotics, or in donor human milk.

Background Obesity and type 2 diabetes mellitus (T2DM) are associated with accelerated brain atrophy, white matter microstructural disruption, and resting-state functional network dysconnectivity in elderly adults, driven by converging vascular, neuroinflammatory, and insulin-resistance mechanisms. Yoga is a recognized mind-body intervention with documented benefits for glycaemic control, vascular health, and neurocognitive function; however, no study has yet employed multimodal MR neuroimaging to systematically characterize these brain alterations in an elderly obese-diabetic population or to evaluate yoga-induced neuroplasticity within this cohort. Methods This three-phase, prospective protocol will be conducted at Kasturba Hospital and the Center for Integrative Medicine and Research, Manipal Academy of Higher Education, Manipal, India. Phase 1 is a case-control study (n = 80; 40 obese-diabetic, 40 obese-non-diabetic; age 60-80 years) employing carotid Doppler ultrasonography, T1-weighted voxel-based morphometry and region-of-interest segmentation (SPM12/CAT12/AAL3), diffusion tensor imaging with ROI-based tractography (ExploreDTI), and resting-state fMRI (CONN toolbox), alongside the Eriksen Flanker and N-Back cognitive tasks. Phase 2 involves the systematic development and expert content-validation of a structured, AYUSH-compliant yoga module tailored for elderly obese-diabetic adults. Phase 3 applies the validated module in a 6-month pre-post intervention, with objective adherence monitoring via triaxial accelerometry and repeat of the full Phase 1 neuroimaging and cognitive battery. Discussion This protocol addresses a critical gap in the yoga-neuroimaging literature by providing a multimodal, multi-phase framework to characterize neurovascular disease burden and evaluate structured yoga as a neurobiologically informed lifestyle intervention in a high-risk elderly population. Findings will inform AYUSH clinical guidelines, geriatric NCD prevention programs, and future randomized controlled trials.

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 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 .

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 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.