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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.

Objectives This study will evaluate the main hypothesis that supplementation with vitamins A, B, C, D, and E significantly improves the severity and mortality rate in ICU patients with COVID-19. Trial design This study is a randomized, single-blinded, two-arm (1:1 ratio) parallel group clinical trial. Participants We are conducting this study in patients with COVID-19 admitted to intensive care units at the Imam Khomeini Hospital Complex in Tehran, Iran. The inclusion criteria are as follows: (1) aged between 20 and 60 years, (2) both male and female patients with COVID-19, (3) clinical or definitive diagnosis (using polymerase chain reaction (PCR) test), (4) patients have not participated in other clinical trials, and (5) no renal or hepatic abnormalities. The exclusion criteria are as follows: (1) patients with specific and rare viral diseases such as HIV and (2) patients who have been undergoing chemotherapy for the past month. Intervention and comparator Duration of intervention: 7 days from randomization Intervention in the treatment group: Vitamin A 25,000 IU daily Vitamin D 600,000 IU once during study Vitamin E 300 IU twice daily Vitamin C is taken four times per day B vitamins are taken as a daily Soluvit [which included thiamine nitrate 3.1 mg, sodium riboflavin phosphate 4.9 mg (corresponding to vitamin B 2 3.6 mg), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to vitamin B 6 4.0 mg), sodium pantothenate 16.5 mg (corresponding to pantothenic acid 15 mg), sodium ascorbate 113 mg (corresponding to vitamin C 100 mg), biotin 60 μg, folic acid 400 μg, and cyanocobalamin 5 μg] The control group will not receive any supplements or placebo. All supplements are made in Iran except for Soluvit (from Fresenius Kabi, New Zealand). Main outcomes Weight, height, and BMI Severity of pulmonary involvement according to CT scan Respiratory support (invasive or non-invasive) Percentage of oxygen saturation (SpO2 level) Serum levels of WBC, CRP, ESR, IL6, IFN-G, and TNF-α The patient’s body temperature The presence or absence of involvement of organs other than the lungs (e.g., heart, liver, kidneys) Duration of hospitalization Mortality rate Randomization At baseline, eligible patients were randomly assigned to a 1:1 ratio to one of two groups: intervention and control. Block randomization is used based on the gender of patients. Blinding (masking) Patients are unaware of being placed in the intervention or control groups after signing consent. All treatment staff will be aware of which group each of the patients is in due to the specific conditions of the ICU and the absence of placebo for the control group. Numbers to be randomized (sample size) The researchers plan to include 60 patients in total, with 30 patients in each group. Trial status This is the first version of the protocol which started on April 2, 2020. Recruitment began April 2, 2020, and is expected to be complete by July 4, 2020. Trial registration The Iranian Registry of Clinical Trials IRCT20200319046819N1 . Registered on April 4, 2020 Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1 ). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol (Fig.  1 , Table  1 ).

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.

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 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.

Many patients with primary brain tumors suffer from cognitive deficits, which negatively impact their quality of life. However, cognitive rehabilitation programs for these patients are scarce. We developed an iPad-based cognitive rehabilitation program for brain tumor patients, which was based on our effective face-to-face cognitive rehabilitation program. After successful completion of a feasibility study, a randomized controlled trial has been started. To evaluate the immediate and long-term effects of the iPad-based program on cognitive performance and patient-reported outcome measures (PROMs) in patients with primary brain tumors in an early stage of the disease. Prior to surgery, patients with presumed low-grade glioma and meningioma are included. Before surgery and 3 mo after surgery, neuropsychological assessments are conducted. After the second neuropsychological assessment, patients are assigned to the intervention group or waiting-list control group. The intervention consists of psychoeducation, compensation training, and retraining. Patients are advised to spend 3 h per week on the program for 10 wk. Immediately after completion of the program and a half-year thereafter, postintervention assessments take place. Patients in the control group are offered the opportunity to follow the program after all study assessments. We expect that early cognitive rehabilitation has beneficial effects on cognitive performance and PROMs in brain tumor patients. The iPad-based program allows brain tumor patients to follow a cognitive rehabilitation program from their homes. Forthcoming results may contribute to further improvement of supportive care for brain tumor patients.

Most people with epilepsy (PWE) could live seizure-free if treated with one or more antiseizure medications (ASMs). The World Health Organization (WHO) estimates that 75% of PWE in low-resource settings lack adequate antiseizure treatment. Limited education surrounding epilepsy and the out-of-pocket costs of ASMs in particular pose barriers to managing epilepsy in resource-poor, low-income settings. The aim of this study is to implement and test a novel strategy to improve outcomes across the epilepsy care cascade marked by (1) retention in epilepsy care, (2) adherence to ASMs, and (3) seizure reduction, with the measured goal of seizure freedom. A randomized, double-blinded clinical trial will be performed, centered at the Ignace Deen Hospital in Conakry, Republic of Guinea, in Western Sub-Saharan Africa. Two hundred people with clinically diagnosed epilepsy, ages 18 years and above, will receive education on epilepsy and then be randomized to (i) free ASMs versus (ii) conditional cash, conditioned upon return to the epilepsy clinic. Participants will be followed for 360 days with study visits every 90 days following enrollment. We design a randomized trial for PWE in Guinea, a low-resource setting with a high proportion of untreated PWE and a nearly completely privatized healthcare system. The trial includes a conditional cash transfer intervention, which has yet to be tested as a targeted means to improve outcomes for people with a chronic neurological disorder. The trial aims to provide an evidence base for the treatment of epilepsy in such settings. We present a clinical trial protocol for a randomized, blinded study of 200 people with epilepsy in the low-resource African Republic of Guinea, providing an educational intervention (E), and then randomizing in a 1:1 allocation to either free antiseizure medication (m) or conditional cash (c ) for 360 days. Measured outcomes include (1) returning to outpatient epilepsy care, (2) adherence to antiseizure medications (ASMs), and (3) reducing the number of seizures. This study is an initial look at giving small amounts of cash for desired results (or \"nudges\") for improving epilepsy outcomes in the sub-Saharan African and brain disorder contexts.

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 .

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.