Risultati per: Linea guida sullo standard di assistenza medica nel diabete

Introduction
Milk fat globule membrane (MFGM) is a complex lipid–protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formula-fed full-term infants.

Methods and analysis
This is a randomised, controlled, clinician-blinded, researcher-blinded and participant-blinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group.

Ethics and dissemination
The Women’s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/19/WCHN/140). Caregivers gave written informed consent prior to enrolling in the trial. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number
ACTRN12620000552987; Australian and New Zealand Clinical Trial Registry: anzctr.org.au.

Rationale
Acute hypoxaemic respiratory failure (AHRF) is associated with high mortality in sub-Saharan Africa. This is at least in part due to critical care-related resource constraints including limited access to invasive mechanical ventilation and/or highly skilled acute care workers. Continuous positive airway pressure (CPAP) and high-flow oxygen by nasal cannula (HFNC) may prove useful to reduce intubation, and therefore, improve survival outcomes among critically ill patients, particularly in resource-limited settings, but data in such settings are lacking. The aim of this study is to determine whether CPAP or HFNC as compared with standard oxygen therapy, could reduce mortality among adults presenting with AHRF in a resource-limited setting.

Methods
This is a prospective, multicentre, randomised, controlled, stepped wedge trial, in which patients presenting with AHRF in Uganda will be randomly assigned to standard oxygen therapy delivered through a face mask, HFNC oxygen or CPAP. The primary outcome is all-cause mortality at 28 days. Secondary outcomes include the number of patients with criteria for intubation at day 7, the number of patients intubated at day 28, ventilator-free days at day 28 and tolerance of each respiratory support.

Ethics and dissemination
The study has obtained ethical approval from the Research and Ethics Committee, School of Biomedical Sciences, College of Health Sciences, Makerere University as well as the Uganda National Council for Science and Technology. Patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.

Trial registration number
NCT04693403.

Protocol version
8 September 2023; version 5.

Secondo il Crea Sanità solo il 55% degli italiani vive in Regioni con risultati soddisfacenti per la tutela della salute

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.

Introduction
Education is recognised as an effective and necessary approach in chronic low back pain. Nevertheless, data regarding the effectiveness of education in promoting physical activity in the medium term or long term are still limited, as are the factors that could lead to successful outcomes. Our study aims to assess the effectiveness of a pain neuroscience education programme compared with traditional back school on physical activity 3 months and 1 year after educational sessions coupled with a multidisciplinary rehabilitation programme. Additionally, we seek to evaluate the effects of these educational interventions on various factors, including pain intensity and psychobehavioural factors. Finally, our goal is to identify the determinants of success in educational sessions combined with the rehabilitation programme.

Methods and analysis
The study will involve 82 adults with chronic low back pain. It will be a monocentric, open, controlled, randomised, superiority trial with two parallel arms: an experimental group, ‘pain neuroscience education’, and a control group, ‘back school’. The primary outcome is the average number of steps taken at home over a week, measured by an actigraph. Secondary outcomes include behavioural assessments. Descriptive and inferential analysis will be conducted. Multivariate modelling will be performed using actimetric data and data from the primary and secondary outcomes.

Ethics and dissemination
The Committee for Personal Protection of Ile de France VII (CPP) gave a favourable opinion on 22 June 2023 (National number: 2023-A00346-39). The study was previously registered with the National Agency for the Safety of Medicines and Health Products (IDRCB: 2023-A00346-39). Participants signed an informed consent during the inclusion visit. This protocol is the version submitted to the CPP entitled ‘Protocol Version N°1 of 03/29/2023’. The results of the study will be presented nationally and internationally through conferences and publications.

Trial registration number
NCT05840302.

Si tratta di medicinali spesso essenziali finora reperibili solo nelle farmacie degli ospedali

Introduction
The 2020 American Heart Association guidelines encourage lay rescuers to provide chest compression-only cardiopulmonary resuscitation to simplify the process and encourage cardiopulmonary resuscitation initiation. However, recent clinical trials had contradictory results about chest compression-only cardiopulmonary resuscitation. This study will aim to compare standard and chest compressions-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest.

Methods and analysis
This study will retrieve only randomised and quasi-randomised controlled trials from the Cochrane Library, PubMed, Web of Science and Embase databases. Data on study design, participant characteristics, intervention details and outcomes will be extracted by a unified standard form. Primary outcomes to be assessed are hospital admission, discharge, and 30-day survival, and return of spontaneous circulation. The Grading of Recommendations, Assessment, Development and Evaluation framework will evaluate the quality of evidence. Cochrane’s tool for assessing the risk of bias will evaluate risk deviation. If the I2 statistic is lower than 40%, the fixed-effects model will be used for meta-analysis. Otherwise, the random-effects model will be used. The search will be performed following the publication of this protocol (estimated to occur on 30 December 2024).

Discussion
This study will evaluate the effect of chest compression-only cardiopulmonary resuscitation after out-of-hospital cardiac arrest and provide evidence for cardiopulmonary resuscitation guidelines.

Ethics and dissemination
No patient or public entity will be involved in this study. Therefore, the study does not need to be ethically reviewed. The results of the study will be disseminated through peer-reviewed journal publications and committee conferences.

PROSPERO registration number
CRD42021295507.

Evento promozionale in oltre 15 località

Annals of Internal Medicine, Ahead of Print.

Annals of Internal Medicine, Ahead of Print.