Conectar
To explore the experiences and support needs of Black Canadian parents with preterm infants and to engage them in co-creating a culturally informed framework to inform nurses, healthcare providers and community organisations to better serve this population.
Preterm birth (PTB) is a traumatic experience that places significant physical and emotional strain on families and other caregivers. Despite research showing that Black mothers are at risk of PTB, little is known about their experiences of giving birth to a preterm infant and the challenges they encounter caring for these children in Canada. This lack of research specifically on Black parents in Canada makes it difficult to identify their psychosocial needs and develop intervention programmes to address their unique challenges.
A two-phase qualitative exploratory design informed by a community engagement lens will be used.
In Phase 1, five focus groups (n = 48) and 6–8 in depth interviews will be conducted with Black parents of preterm infants. Questions will explore experiences in the NICU, transition home, access to support, coping strategies and mental well-being. One focus group will be conducted with the parent advisory council of the Canadian Premature Babies Foundation, our community partner to explore gaps in services. The data from Phase 1 will be analysed and findings will be used to informed Phase 2 concept mapping exercise. This research was approved by the Toronto Metropolitan University Research Ethics Board.
There is a paucity of research addressing the experiences and needs of Black parents with preterm infants. Thus, this study is well positioned to generate the much-needed Canadian empirical knowledge on the unique experiences and stressors face by Black parents with preterm infants and inform the design of programmes and services to better support them.
This study is in collaboration with the Canadian Premature Babies Foundation, our community partner.
Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of 9-tetrahydrocannabinol (9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.
This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.
This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.
Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.
The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).
To examine how the population composition, practice organisation and geographical context of general practice clinics are associated with unwarranted variation in prescribing patterns (variation not explained by patient characteristics), using potentially inappropriate medication (PIM) as an indicator of treatment quality.
A nationwide register-based cohort study.
Data on eligible general practice clinics (1703 clinics) in Denmark and their listed patient populations (4 369 915 individuals) were collected from 1 January to 31 December 2021.
Unwarranted variation in PIM was estimated using the clinics’ PIM propensity. PIM propensity in clinics was defined as the ratio between observed and expected PIM incidence among listed patients and was stratified into indicators of underprescribing and overprescribing.
The results demonstrate a 13% difference in PIM propensity between clinics with the highest propensity (90th percentile) and the lowest propensity (10th percentile). When stratifying by underprescribing and overprescribing, we found a relative difference of 12% for underprescribing and 50% for overprescribing between the two groups. Clinics serving male-dominated populations (>55% men 1.11, 95% CI 1.08 to 1.14) and more socially deprived patient populations (deprivation index >40 10.11, 95% CI 1.08 to 1.14) had a higher propensity for overprescribing. Organisational factors associated with overprescribing included single-handed practices (1.08, 95% CI 1.06 to 1.10), smaller patient lists (100 000 citizens: 1.04, 95% CI 1.02 to 1.07). In contrast, disease burden and age distribution in listed patients appeared to have no clinically relevant association with PIM propensity.
This study indicates unwarranted variation in the medical treatment quality, primarily related to overprescribing. Inferior treatment quality was associated with patient composition, practice organisation and geographical context. This emphasises a need for new strategies to address the inverse care law and enhance patient safety.
To explore the familial, emotional, social and school-related challenges experienced by school-aged siblings of children with cancer, focusing on how these challenges intersect across hospital, home and school in their everyday lives.
Qualitative, two-phase, multi-site study.
Fieldwork was conducted at two distinct paediatric oncology wards, followed by semi-structured interviews with 11 siblings (aged 7–19 years) and 20 parents, recruited through criterion-based sampling. The data were analysed using reflexive thematic analysis.
Analysis showed that siblings were often marginalised in hospital life due to (1) family logistics; (2) hospital-induced restrictions, rules and physical spaces and (3) perceptions of their presence as ‘problematic’, ultimately limiting their access. In family life, siblings experienced peripheral roles because (1) they were cared for by others, (2) had their needs subordinated and (3) faced shifting expectations. At school, siblings encountered (1) limited understanding from classmates and teachers and (2) insufficient support resources.
Siblings of children with cancer face significant, interconnected challenges, often amplified by the structural frameworks of healthcare, family and school contexts.
Siblings of children with cancer are often marginalised in their own lives. In healthcare, a family-centred approach to care should formally and actively include siblings. Nurses are well-positioned to promote this, ensuring whole-family support. Siblings would benefit from coordinated support bridging hospital, home and school.
This study adheres to the SRQR Checklist.
Parents helped shape the study focus by discussing preliminary observations and potential support needs.
In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.
CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.
This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.
CRD42024629656.
The objective of this study was to generate evidence for strengthening the local food system to contribute to improved dietary diversity among children in Ethiopia.
A community-based cross-sectional survey.
The study was conducted in the Amhara, Oromia and Somali regions of Ethiopia.
A total of 1475 children aged 6–23 months were included. Children requiring special care or not permanently residing in the study areas were excluded.
The primary outcome measure was the adequate Minimum Dietary Diversity, defined as the consumption of at least five of the eight defined food groups in the previous 24 hours.
Only 25.6% of children met the adequate minimum dietary diversity requirement. Children from households with backyard gardening (Adjusted odds ratio (AOR)=1.43, 95% CI 1.08 to 1.88), access to communication devices (AOR=1.99, 95% CI 1.51 to 2.64), attendance at cooking demonstrations (AOR=1.99, 95% CI 1.44 to 2.74), use of labour-saving and time-saving technologies (AOR=1.55, 95% CI 1.15 to 2.09) and irrigation use for crop production (AOR=1.78, 95% CI 1.26 to 2.52) had higher odds of meeting adequate minimum dietary diversity. Residence was strongly associated with dietary outcomes: children in Amhara had more than seven times the odds of achieving adequate minimum dietary diversity of children compared with Somali (AOR=7.56, 95% CI 4.92 to 11.62), while those in Oromia had nearly twice the odds (AOR=1.74, 95% CI 1.17 to 2.60).
Dietary diversity among children was low in the study areas. Strengthening local food systems through promotion of backyard gardening, cooking demonstrations, irrigation use, communication access and appropriate technologies could improve children’s dietary diversity. Regional disparities highlight the need for context-specific strategies, particularly to address the low dietary diversity in children.
Cardiovascular disease (CVD) risk remains high but unevenly distributed in patients with type 2 diabetes mellitus (T2DM). Current risk stratification strategies are far from optimal, leading to both undertreatment and overtreatment of patients. The STENO INTEN-CT trial aims to evaluate a strategy of improved CVD risk management by using cardiac CT (coronary artery calcification (CAC)) for stratification and tailoring of multifactorial cardiovascular treatment based on CAC score. We hypothesise that (1) intensified medical treatment will lower CVD event rates in high-risk patients (CAC≥100), and (2) less intensive multifactorial treatment is safe in very low-risk patients (CAC=0).
The Steno INTEN-CT trial is an investigator-initiated, pragmatic, open-label, event-driven randomised controlled trial including patients with T2DM without known CVD. All participants (expected n=7300) will be invited for a non-contrast coronary CT scan. After the scan, participants will be randomised to either standard treatment (blinded for CAC results) or CAC-based treatment. Participants in CAC-based treatment and their general practitioner (GP) will receive information on CAC and a recommendation of multifactorial treatment. High-risk participants in the interventional arm will be invited for one or more initial study visits to intensify treatment with a combination of sodium glucose co-transporter 2 inhibitors, glucagon-like peptide 1 receptor agonists, high-dose lipid-lowering, antihypertensive and antithrombotic treatment. Very low-risk patients in the interventional arm will be recommended less intensive treatment targets. After initial study-related activities, all participants will continue to be taken care of by their GP guided by specific treatment recommendations. The primary outcome in the primary hierarchical analysis (the rate of the combined CVD endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalisation for heart failure) will be monitored through national health registries. The trial is event-driven, but a median follow-up of 5 years is expected. Key secondary outcomes include patient-reported outcomes, quality-adjusted life years and healthcare costs.
The protocol V.1.9 is approved by the Research Ethics Committee and the Danish Medicines Agency and the Danish Data Protection Agency. The results of the study—positive, negative or neutral—will be published in peer-reviewed journals and through www.clinicaltrials.org.
by Nailya Ibragimova, Arailym Aitynova, Seitzhan Turganbay, Marina Lyu, Alexandr Ilin, Tamari Gapurkhaeva, Galina Ponomareva, Karina Vassilyeva, Diana Issayeva, Amirkan Azembayev, Serzhan Mombekov, Aralbek Rsaliyev, Nurgul Sikhayeva, Yergali Abduraimov, Saki Raheem
Iodine-based antiseptics are essential in wound care but are often limited by cytotoxicity, instability, and rapid iodine release. Novostron is a novel polymer–iodine complex incorporating dextrin, polyvinyl alcohol, and metal ions, designed to enable controlled iodine release. Structural integrity and composition were confirmed by ¹H and 13C NMR spectroscopy and physicochemical analysis, indicating a molecular weight of ~9500 g/mol, a pH of 4.23, and an iodine content of 8.13%. Pharmacokinetic analysis in rabbits demonstrated that following a single dermal application, systemic iodine absorption was minimal, with peak blood iodine concentrations remaining within physiological limits and rapid elimination within 24 hours. Evaluation of thyroid function revealed no significant changes in serum T₃, T₄, or TSH levels compared with those of the controls, confirming that topical application of Novostron does not disrupt thyroid homeostasis. In compliance with OECD guidelines in rabbits, guinea pigs, and rats, Novostron showed no signs of dermal irritation, skin sensitization, or systemic toxicity (LD₅₀ > 2000 mg/kg). In a rat cotton pellet granuloma model, Novostron significantly reduced the inflammatory mass (23.65% inhibition), supporting its anti-inflammatory potential. In a murine burn model, Novostron accelerated wound contraction (25.95% at day 10), increased epidermal thickness, and enhanced collagen deposition (~44%), outperforming controls and matching or exceeding betadine. These findings suggest that Novostron promotes tissue repair by modulating inflammation. Overall, Novostron demonstrated a favourable preclinical safety and efficacy profile, and its polymer–iodine composition, which enables controlled release and localized activity highlights its potential as a promising topical therapeutic. However, the study was limited to animal models and short-term observation; further long-term and clinical investigations are needed to confirm its translational potential in human wound healing.by Merga Abdissa Aga
We propose the Fréchet–Power Function (FPF) distribution, a novel two-parameter model that combines the bounded support of the Power Function distribution with the heavy-tailed flexibility of a Fréchet-type generator. This combination enables the FPF to capture complex features such as skewness, heavy tails, and diverse hazard rate shapes—limitations present in existing bounded lifetime models. We provide explicit forms for the probability density, cumulative distribution, and quantile functions, along with detailed statistical properties including moments and hazard rate behavior. Parameters are estimated using maximum likelihood, with bootstrap and simulation techniques employed to assess estimator performance. Empirical applications to survival, reliability, and environmental datasets show that the FPF distribution consistently outperforms traditional models in terms of goodness-of-fit and flexibility. This work introduces a powerful and versatile tool for modeling bounded lifetime data, offering enhanced accuracy and interpretability across disciplines.A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.
We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.
Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.
To achieve a deeper understanding of the results of a primary randomised controlled trial to clarify the potential effective mechanisms and barriers of a peer-mentor intervention.
Mixed methods process-outcome evaluation of the intervention.
Qualitative and quantitative data were collected during the intervention in a during-trial set-up, that is, a convergent design.
The qualitative and quantitative findings mostly confirmed and expanded each other, identifying several mechanisms that facilitate the effectiveness of peer-mentor support during cardiac rehabilitation, such as mentors' experience-based knowledge and motivation. However, barriers related to lifestyle changes among older, vulnerable patients (e.g., mentee concerns about heart-healthy diets) and psychological outcomes (e.g., mentees' resilience) may minimise the effectiveness.
Peer-mentoring holds potential for supporting older, vulnerable patients during cardiac rehabilitation. However, ensuring that peer-mentors are well-suited for their role and capable of providing motivational, experience-based support is crucial, as is the need for tailored mentorship and consideration of specific patient populations needing mentor-supported cardiac rehabilitation.
Cardiac rehabilitation faces challenges due to high drop-out rates, particularly among older individuals, females, and vulnerable patients. Peer mentoring, a low-cost intervention, holds promise for supporting these groups in cardiac rehabilitation programmes.
The study adheres to the ‘Systematic Development of Standards for Mixed Methods Reporting in Rehabilitation Health Sciences Research’, ‘Good Reporting of A Mixed Methods Study’ and ‘Template for Intervention Description and Replication’.
A group of patients with cardiovascular disease actively contributed to developing and implementing the intervention.
ClinicalTrials.gov Identifier: NCT04945486—prospectively registered before the first participant was recruited
To explore how parents of children with de novo retinoblastoma (RB) experience the diagnostic process and acute treatment phase, and to identify factors that may support parental coping and adaptation.
A qualitative interview study using reflexive thematic analysis.
National Retinoblastoma Unit at Aarhus University Hospital, Denmark.
Thirty-one parents (21 mothers, 10 fathers) of 21 children diagnosed with de novo RB were recruited via hospital follow-up clinics and a support group day.
For most parents, the diagnostic process was short. In cases of diagnostic delay, parents described frustration and guilt due to missed symptoms. Receiving the RB diagnosis was described as a surreal experience, accompanied by feelings of shock, grief and loss of control. Parents faced challenges in adapting to rapid medical decisions and the unfamiliar demands of hospital protocols. However, meeting the clinical experts was a relief, as parents felt they were in capable hands, experiencing empathetic communication and a clearly framed treatment plan. Parents emphasised the importance of support systems, including family, healthcare professionals and the child’s resilience, as crucial for coping with and managing the diagnosis.
Parents faced a sudden and disruptive transition from symptom recognition to life-altering diagnosis and treatment. While professional care and communication were experienced as supportive, they did not eliminate the emotional impact. Clinical pathways should prioritise early validation of parental concerns and provide transparent communication, both prior to referral and throughout treatment. Future research should examine longer-term parental adjustment and identify interventions that support emotional resilience beyond the acute phase.
The study aims to explore the experiences of Black Canadian parents following a preterm birth and their perspectives of being in the NICU.
A qualitative design guided by principles of community engagement was used to explore the experiences of Black Canadian parents.
Focus groups and in-depth interviews were conducted with 40 Black parents of preterm infants. A thematic analysis approach was used to organize the data into meaningful themes.
Five major themes were identified through the data analysis: encountering racism and discrimination in the NICU, bearing the emotional weight of staying in the NICU, enduring the feeling of bodily betrayal and guilt, grappling with the turmoil of uncertainty and seeking peer and mental health support programs.
This study provides in-depth understanding of the unique experiences of Black Canadian parents after a preterm birth and the challenges they face navigating the NICU.
Developing a targeted training program for health care providers is critical to address racism and discriminatory practices and enhance parents' sense of belonging in the NICU. Creating Black-focused peer support and accessible mental health care during and after the NICU is critical to address the gaps in programs and services and to promote effective coping.
Addressing racism and discriminatory practice requires urgent attention to promote equity within the NICU environment. Scaling up access to Black peer support and mental health programs will contribute to improving parental wellbeing in Canada and beyond.
This study was in partnership with the Canadian Premature Babies Foundation, our community collaborator.
To evaluate the impact of video use in out-of-hours primary care (OOH-PC) telephone triage by examining how triage outcomes (ie, ended by telephone, clinic consultation or home visit) changed during a period with video service failure.
Observational register-based study, using periods of video service failure as a randomisation mechanism for a controlled study.
OOH-PC in four of the five Danish regions.
All telephone triage contacts to the OOH-PC call centres between April 2020 and December 2021.
Video service failures resulted in a subset of telephone triage contacts without the option of using video as a triage tool. Video service failures were identified algorithmically based on observed periods without video use.
Proportion of telephone triage contacts with clinic consultations or home visits as triage outcome during a period of video service failure compared with matched reference telephone triage contacts taking place during normal service (1:10), presented as risk ratios (RR) with 95% CI).
The algorithm identified 6605 telephone triage contacts during video service failure. Compared with matched contacts during normal service, these had a 15% higher risk of resulting in a clinic consultation (RR: 1.15, 95% CI 1.09 to 1.20). This effect was primarily isolated to the year 2021 (RR: 1.23, 95% CI 1.16 to 1.31) compared with 2020 (RR: 1.05%, 95% CI 0.97 to 1.13). Video service failure did not significantly affect the risk of a home visit.
Results strongly suggest that the unavailability of the video service is likely to significantly increase the number of clinic consultations in OOH-PC as a triage outcome. Whether this effect is likely to persist in the long term remains unclear.
Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.
To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.
Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.
Electronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.
Eligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.
Search results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.
A total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.
This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.
The protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).
To summarise the effect of mentoring within mentoring programmes on the retention and turnover of newly graduated nurses in healthcare settings.
An umbrella review.
Two independent reviewers screened the titles, abstracts and full texts for eligibility and critically appraised the included reviews using the JBI critical appraisal. The findings were tabulated and synthesised.
The search was conducted in five electronic databases (CINAHL, OvidMedline, ProQuest, Scopus, Cochrane and Medic) in November 2023.
Out of 450 Papers, 13 systematic and integrative reviews were included. Thirteen mentoring programmes were identified and categorised into three groups based on their content: didactic mentoring programmes, interaction-based mentoring programmes and combined mentoring programmes. Across these programme types, retention among newly graduated nurses ranged from 72% to 100% at the 1-year mark and 70% to 98% at 2 years. Turnover rates showed consistent reductions, with post-intervention rates ranging from 3.5% to 20% compared to pre-intervention rates of up to 50%. Several studies reported statistically significant improvements in retention and turnover, particularly in programmes integrating structured education and preceptorship models.
Several different mentoring programmes have been developed to support the transition of newly graduated nurses. Mentoring programmes that provide ongoing support and structured guidance increase retention and reduce turnover among newly graduated nurses.
Effective mentoring programmes are key to ensuring high-quality patient care and a sufficient supply of qualified nurses in the future.
The findings can provide information for developing transition support and mentoring programmes for newly graduated nurses.
This umbrella review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.
No patient or public contribution.
The umbrella review protocol was registered in PROSPERO: CRD42023478044.
Improving the quality of life for preterm children is a global health priority, given their vulnerability to neurocognitive impairments and adverse health consequences. Lack of posthospital care further exacerbates these risks, necessitating effective interventions during the neonatal period. This protocol for a pilot study aims to investigate the effects of touch interventions, including physiotherapy and osteopathic manipulative treatment, on brain activity in moderately preterm infants using brain functional MRI (fMRI), computerised EEG and metabolomics.
A 3-arm randomised sham-controlled trial will be conducted with 15 infants per experimental group. The study will include stable preterm infants born between 32.0 and 33.6 weeks of gestational age who do not require any intensive care treatments.
The study aims to assess the impact of touch interventions on brain activity and metabolic sequelae. Using fMRI will primarily examine the pre-post changes between groups in blood oxygenation level dependent levels among different brain areas, specifically the anterior insula and the medial prefrontal cortex. Secondarily, we will explore the preterm brain’s neural effects on EEG slow delta wave band. Metabolomics will provide data on the effects among the three groups on metabolic changes associated with touch interventions.
Ethical approval has been obtained from the Ethics Committee of the local health agency in Milan (CET 449-2024). Understanding the effects of touch interventions on brain activity in moderately preterm infants, without needs of intensive care, can contribute to improving their clinical outcomes and promoting their growth, development and social behaviour. Findings from this pilot study will pave the way for future research, enabling the development of evidence-based interventions to enhance preterm infants’ well-being and long-term outcomes.
Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.
This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.
This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.
FreshRSS 