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Safety and efficacy of whole-body chlorhexidine gluconate cleansing with or without emollient in hospitalised neonates (NeoCHG): a multicentre, randomised, open-label, factorial pilot trial.
BACKGROUND: Healthcare-associated infections account for substantial neonatal in-hospital mortality. Chlorhexidine gluconate (CHG) whole body skin application could reduce sepsis by lowering bacterial colonisation density, although safety and optimal application regimen is unclear. Emollients, including sunflower oil, may independently improve skin condition, thereby reducing sepsis. We aimed to inform which concentration and frequency of CHG, with or without emollient, would best balance safety and the surrogate marker of efficacy of reduction in bacterial colonisation, to be taken forward in a future pragmatic trial evaluating clinical outcomes of sepsis and mortality. METHODS: In this multicentre, randomised, open-label, factorial pilot trial, neonates in two hospital sites (South Africa, Bangladesh) aged 1-6 days with gestational age ā„ 28 weeks and birthweight 1000-1999 g were randomly assigned in a factorial design stratified by site to three different concentrations of CHG (0.5%, 1%, and 2%), with or without emollient (sunflower oil) applied on working days vs alternate working days. A control arm received neither product. Caregivers were unblinded although laboratory staff were blinded to randomisation Co-primary outcomes were safety (change in neonatal skin condition score incorporating dryness, erythema, and skin breakdown) and efficacy in reducing bacterial colonisation density (change in total skin bacterial log10Ā CFU from randomisation to day-3 and day-8). The trial is registered at the ISRCTN registry, ISRCTNĀ 69836999. FINDINGS: Between Apr 12 2021 and Jan 18 2022, 208 infants were randomised and 198 were included in the final analysis. Skin condition scores were low with mean 0.1 (sdĀ =Ā 0.3; NĀ =Ā 208) at baseline, 0.1 (sdĀ =Ā 0.3; NĀ =Ā 199) at day 3 and 0.1 (sdĀ =Ā 0.3; NĀ =Ā 189) at day 8, with no evidence of differences between concentration (1% CHG vs 0.5% estimateĀ =Ā -0.3, 95% CIĀ = (-1.2, 0.6), pĀ =Ā 0.55. 2% CHG vs 0.5% CHG estimateĀ =Ā 0.5 (-0.4, 1.4), pĀ =Ā 0.30), increasing frequency (estimateĀ =Ā -0.4; 95% CIĀ = (-1.1, 0.4), pĀ =Ā 0.33), emollient (estimateĀ =Ā -0.5, (-1.2, 0.3), pĀ =Ā 0.23) or with control (estimateĀ =Ā -0.9, (-2.3, 0.4), pĀ =Ā 0.18). Mean log10Ā CFU was 4.9 (sdĀ =Ā 3.0; NĀ =Ā 208) at baseline, 6.3 (sdĀ =Ā 3.1; NĀ =Ā 198) at day 3 and 8.4 (sdĀ =Ā 2.6; NĀ =Ā 183) with no evidence of differences between concentration (1% CHG vs 0.5% estimateĀ =Ā -0.4; 95% CIĀ = (-1.1, 0.23); pĀ =Ā 0.23. 2% CHG vs 0.5% CHG estimateĀ =Ā 0.0 (-0.6, 0.6), pĀ =Ā 0.96), with increasing frequency (estimateĀ =Ā -0.4; 95% CIĀ = (-0.9, 0.2); pĀ =Ā 0.17), with emollient (estimateĀ =Ā 0.4, 95% CIĀ = (-0.2, 0.9); pĀ =Ā 0.18) or with control (estimateĀ =Ā -0.2, 95% CIĀ = (-1.3, 0.9); pĀ =Ā 0.73). By day-8, overall 158/183 (86%) of neonates were colonised with Enterobacterales, and 72/183 (39%) and 69/183 (9%) with Klebsiella spp resistant to third-generation cephalosporin and carbapenems, respectively. There were no CHG-related SAEs, emollient-related SAEs, grade 3 or 4 skin scores or grade 3 or 4 hypothermias. INTERPRETATION: In this pilot trial of CHG with or without sunflower oil, no safety issues were identified, and further trials examining clinical outcomes are warranted. The relatively late start application of emollient, at a mean of 3.8 days of life, may have reduced the impact of the intervention although no subgroup effects were detected. There was no clear evidence in favour of a specific concentration of chlorhexidine, and there was rapid colonisation with Enterobacterales with frequent antimicrobial resistance, regardless of skin application regimen. FUNDING: The MRC Joint Applied Global Health award, the Global Antibiotic Research and Development Partnership (GARDP), MRC Clinical Trials Unit core funding (UKRI) and St. George's, University of London
Inmate cancer patient - Highlighting the importance of a holistic approach to oncological care
Purpose: Inmate oncologic patients' rates increased drastically worldwide. Elderly, limited exercise, unhealthy diet, hepatitis, HIV + status, tobacco and alcohol use, constitute the main cancer risk factors. We present an outline of practical oncological management and ethical thinking, in the specific environment of a detention facility. Methods: PubMed, Cochrane Database of Controlled Trials, SCOPUS and grey literature were extensively searched up to October 2021. Incarcerated oncologic patients experience various everyday challenges:their confinement in high security facilities, the lack of access to critical care and related ethical dilemmas inherent to the context of a correctional facility. Results: The detention facilities may be inadequate in providing early cancer diagnosis and appropriate care mainly due to a lack of specialized personnel, b) in-house or in external specialized cancer hospitals, care variability (e.g. admissions in small local or regional hospitals), c) delays in providing access and d) gatekeeper systems. There is a paucity of administration of a)systemic therapy (chemotherapy, targeted drug therapy etc),b)radiotherapy, c) palliative care, and d)enrollment in clinical trials. Conclusions: Correctional facilities must encourage teamwork between healthcare and correctional professionals in order to improve the provided anticancer care. Ā© 2021 Zerbinis Publications. All rights reserved
Nationwide survey in greece about knowledge, risk perceptions, and preventive behaviors for covid-19 during the general lockdown in april 2020
Background: The aim of this study was to investigate the knowledge, attitudes, and practices of the Greek general population toward coronavirus disease 2019 (COVID-19) during the lockdown period in April 020, to examine factors associated with misperceptions and to determine behavioral patterns that may require interventions. Methods: A cross-sectional study of the general Greek population (N = 1858) was conducted. A geographically stratified cluster sampling was implemented. A questionnaire was composed consisting of 35 questions. Data collection took place from 15 April to 2 May 2020. A random-digit dialing survey was conducted by 29 interviewers. Results: The majority of respondents (62.7%) answered ā„12/17 questions correctly. Participants aged 18ā44 years, male gender, specific occupations (freelancer, unemployed, housewife, retiree) and those who sought information about COVID-19 from less than two sources received lower aggregated scores on knowledge questions. Regarding attitudes toward future vaccination, 18.9% declared that were against it, while 81.1% that they may consider or will be vaccinated. About 40% were not using a face mask and only 42% washed their hands appropriately. Conclusion: Adjusting information campaigns targeting especially people below 45 years of age can help to sensitize them and realise their role to control the spread. Further targeted surveys are needed to adjust/design prevention campaigns. Ā© 2020 by the authors. Licensee MDPI, Basel, Switzerland
Nationwide Survey in Greece about Knowledge, Risk Perceptions, and Preventive Behaviors for COVID-19 during the General Lockdown in April 2020
Background: The aim of this study was to investigate the knowledge, attitudes, and practices of the Greek general population toward coronavirus disease 2019 (COVID-19) during the lockdown period in April 2020, to examine factors associated with misperceptions and to determine behavioral patterns that may require interventions. Methods: A cross-sectional study of the general Greek population (N = 1858) was conducted. A geographically stratified cluster sampling was implemented. A questionnaire was composed consisting of 35 questions. Data collection took place from 15 April to 2 May 2020. A random-digit dialing survey was conducted by 29 interviewers. Results: The majority of respondents (62.7%) answered ≥12/17 questions correctly. Participants aged 18–44 years, male gender, specific occupations (freelancer, unemployed, housewife, retiree) and those who sought information about COVID-19 from less than two sources received lower aggregated scores on knowledge questions. Regarding attitudes toward future vaccination, 18.9% declared that were against it, while 81.1% that they may consider or will be vaccinated. About 40% were not using a face mask and only 42% washed their hands appropriately. Conclusion: Adjusting information campaigns targeting especially people below 45 years of age can help to sensitize them and realise their role to control the spread. Further targeted surveys are needed to adjust/design prevention campaigns