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Protocol for a randomised, double-blind, placebo-controlled clinical trial on the effects of high-dose vitamin B multivitamin supplementation with and without Passiflora incarnata on neural connectivity and oxidative metabolism in healthy adults

Por: Yeong · C. H. · Wong · Y. H. · Lim · S. Y. · Tan · B. K. · Seerangam · S. · Chinna · K. · Ramli · N. · Rahmat · K. · Nawawi · O. · Tan · L. K. · Che Ahmad · A. · Stajic · V. · Tay · J. P.
Introduction

B-vitamins and herbal supplements such as Passiflora incarnata have demonstrated potential benefits for cognitive and neurological functions. This study aims to evaluate the neural and biochemical effects of high-dose vitamin B multivitamin supplementation, with and without P. incarnata, in healthy adults using multimodal neuroimaging and biomarker assessments.

Methods and analysis

This is a phase I/II, randomised, double-blind, placebo-controlled clinical trial involving 108 healthy adults aged 30–55 years, allocated to three groups: (A) high-dose vitamin B multivitamin supplementation with P. incarnata; (B) high-dose vitamin B multivitamin supplementation alone; and (C) placebo. Participants will take two tablets daily for 24 weeks. The primary outcomes are changes in default mode network connectivity assessed using resting-state functional magnetic resonance imaging and diffusion magnetic resonance imaging, together with safety outcomes including vital signs, clinical laboratory parameters and adverse event monitoring. Secondary outcomes include regional brain metabolite concentrations measured by proton magnetic resonance spectroscopy and plasma biomarkers of one-carbon metabolism, including vitamin B6, vitamin B12, folate and homocysteine.

Ethics and dissemination

Ethics approval was granted by the Medical Research Ethics Committee, Ministry of Health Malaysia (NMRR-19-379-46101 (ISR); Protocol Number: Exec B). Results will be disseminated through peer-reviewed publications and scientific conferences.

Trial registration number

ACTRN12622001150730.

Knowledge and misconceptions regarding choking and first-aid procedures among the general population in the West Bank, Palestine: a cross-sectional study

Por: Hamammdi · A. · Zhour · M. F. · Melhem · F. A. · Tamimi · S. N. S. · Belbaisi · Q. · Jaber · M. S. O. · Awad · B. Y. H.
Objectives

To assess the level of knowledge, attitudes and practices regarding choking first aid among the general population in the West Bank.

Design

A descriptive cross-sectional study.

Setting

West Bank, Palestine (web-based survey).

Participants

454 Palestinian adults aged 18 years and above.

Primary outcome measures

General knowledge concerning signs of choking, misconceptions and proper first-aid manoeuvres (such as the Heimlich manoeuvre and back blows) was assessed. Analysis was performed using SPSS V.26.

Results

A cumulative total of 454 participants took the online survey. Although 55.7% of the participants defined choking accurately, there was still room for improvement in the actual management of this condition. Fewer participants (46.7%) could recognise the picture of the Heimlich manoeuvre and only 14.8% could state the appropriate management for vulnerable groups such as pregnant patients. Harmful misunderstandings existed, with 26% of participants endorsing the blind finger sweep and 32.8% offering water to a choking victim. Multivariable analysis revealed that higher knowledge scores were independently predicted by having a medical background (p=0.007) and previous formal training in first aid (p=0.019).

Conclusions

The general public in this region has shown moderately good theoretical knowledge about choking but lacks competence in practical first aid training and has a remarkably low level of safe practices. There is an urgent need for organised community-based training programmes for first aid in an attempt to bring down morbidity and mortality from choking.

How do acute worsening events influence daily life and healthcare-seeking behaviour in patients with COPD: an international multicountry qualitative study

Por: Dijk · L. · Driessen · M. M. G. · Gerritsma · Y. H. · Bolton · C. · Da Silva · C. · Kocks · J. W. H.
Objective

To explore the impact of acute worsening events (AWEs), defined as clinically relevant deteriorations in peak expiratory flow, reliever use and/or symptoms, on patients’ daily lives and identify behaviours linked to their recognition and management.

Design

A qualitative international substudy was conducted in the Netherlands, Spain, the USA, Canada and the UK (2023–2024).

Participants

19 patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) from a randomised clinical trial participated. Interviews, triggered by AWEs and repeated 6 weeks later, were audio-recorded, transcribed and analysed.

Results

Patients varied in identifying bad days, reporting inability to perform physical activities, symptom worsening or the need for add-on treatment. Recognition of AWEs depended on their duration: shorter events (

Conclusions

AWEs significantly impact daily life but vary widely in recognition and thresholds for seeking care. Limited awareness of daily disease variations may contribute to both under-reporting of worsening events to healthcare providers and suboptimal self-management in COPD.

Trial registration number

NCT05492877.

Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study

Por: Cho · H. · Jung · Y. H. · Park · J. · Yang · H. J. · Kim · M. J. · Lee · J.
Introduction

Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is a promising respiratory support method for avoiding invasive mechanical ventilation in neonatal intensive care units (NICUs). However, its effectiveness and safety have not been widely established through clinical evidence. In this study, we aim to evaluate the feasibility of NIV-NAVA as a primary respiratory support method after birth and its effects on short-term clinical outcomes and long-term neurodevelopment in preterm infants.

Methods and analysis

In this prospective multicentre observational study, 230 preterm infants will be recruited after birth. This study will include preterm infants born between 27+0 and 31+6 weeks of gestation who require respiratory support within the first 48 hours after birth. NIV-NAVA will be initiated as primary respiratory support either immediately after birth or during the early NICU stay, with settings adjusted according to each infant’s clinical condition. Discontinuation of NIV-NAVA or transition to continuous positive airway pressure or high-flow nasal cannula will be performed based on clinical stability. A less invasive surfactant administration method will be used for infants with respiratory distress syndrome to avoid intubation whenever possible. Infants intubated at birth will be extubated to NIV-NAVA as early as is clinically feasible. Invasive ventilation may be applied if clinical deterioration occurs. The rate of NIV-NAVA failure, duration of non-invasive and invasive ventilation, rate of bronchopulmonary dysplasia and clinical outcomes, such as air leak, patent ductus arteriosus, intraventricular haemorrhage and retinopathy of prematurity, will be measured. The neurodevelopmental outcomes of infants will be assessed for up to 3 years.

Ethics and dissemination

The Institutional Review Board (IRB) of Korea University Anam Hospital (2024AN0554) and Seoul National University Bundang Hospital (IRB No. B-2507-984-304) approved this study. The results will be disseminated through scientific conferences and publications.

Trial registration number

NCT06786039 registered on 14 January 2025.

Beyond protocols: what are nurses lived experiences and perceived systemic barriers in central venous catheter management in a resource-limited tertiary hospital in Ghana? A qualitative study

Por: Rajah · M. R. · Yakubu · Y. H.
Objective

To explore nurses’ experiences of central venous catheter (CVC) management in a resource-limited tertiary hospital.

Design

A qualitative exploratory-descriptive study using in-depth, semistructured interviews.

Setting

A low-resource tertiary care facility in Ghana, West Africa.

Participants

13 registered nurses working in intensive and critical care units.

Methods

Individual semistructured interviews were conducted and analysed using reflexive thematic analysis.

Results

Four (4) main themes and 14 related subthemes were identified. The main themes included (1) system constraints shaping CVC care (supplies, infrastructure and workload); (2) practice and protocol feasibility (infection prevention and workarounds); (3) capability building and support (knowledge/skills, practical training, supervision and mentoring and nurses’ voice) and (4) psychosocial impact (burnout, fear of complications and limited emotional support). Nurses described confidence in routine tasks but reported limited support for managing complications and sustaining protocol adherence.

Conclusions

In resource-limited settings, effective CVC management extends beyond individual clinical competence and requires robust institutional support, adequate staffing, ongoing professional development and responsive organisational systems. Addressing these structural and psychosocial factors is essential to improving nursing practice, enhancing patient safety and supporting global infection prevention priorities.

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