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Trial status | RECRUITMENT | VISAGE trial has begun recruitment in March 2021. As of December 2022, 33/82 patients (40,2%) have been included. | PMC10084642 | |
Acknowledgements | We acknowledge all patients and therapists who support the study. | PMC10084642 | ||
Authors’ contributions | MB planned the study, wrote the grant application, and the protocol for the Ethics Committee for this project. MB is the principal investigator of this study. MB participated in data collection and drafted the manuscript. MB, EA and JMG contributed to developing the protocol, drafting the manuscript, and checked the final draft of the manuscript. All authors read and approved the final manuscript. | PMC10084642 | ||
Authors’ information | Neurolocomotrice | MONDOR |
- Dr Marjolaine Baude, Hôpitaux Universitaires Henri Mondor, Service de Rééducation Neurolocomotrice, Créteil; marjolaine.baude@aphp.fr;- Dr Ludovic Bénichou, Hôpital Saint-Joseph, Service de Chirurgie Maxillo-faciale, Paris; lbenichou@hpsj.fr;- Pr André Coste, Intercommunal Centre de Créteil, Service d’Oto-Rhino-Laryngologie, Créteil; andre.coste@chicreteil.fr;- Pr Jean-Paul Méningaud, Hôpitaux Universitaires Henri Mondor, Service de Chirurgie Plastique, Créteil; meningaud@me.com.
The coordinating center is the following: | PMC10084642 |
Availability of data and materials | MONDOR | The dataset supporting this article is available at Henri Mondor University Hospitals, at the Clinical Research Unit, 1 rue Gustave Eiffel, 94,000 Créteil, France.
Any substantial modification of the protocol by the coordinating investigator must be transmitted to the sponsor for approval. After this approval, the sponsor must obtain a favorable opinion from the IRB prior to its implementation. Relevant parties (investigators, REC/IRBs, trial participants) will be contacted for
communicating important protocol modifications by the coordinating investigator and/or the Clinical Research Unit by postal or electronic mail depending on the situation.
Personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial using a secured online database (eCRF) and an internal hospital server containing the password-protected database.
The sponsor AP-HP is the owner of the data. The data cannot be used or disclosed to a third party without its prior permission. Investigators and sponsor will communicate on trial results to participants, professionals and public through publications and oral and/or writing communications. The Coordinator investigator of each center including at least one patient will be eligible to authorship. Manuscripts related to the study results will be reviewed by a professional writer. The VISAGE project is registered on the APHP clinical research registry, free online access: | PMC10084642 | |
Declarations | PMC10084642 | |||
Ethics approval and consent to participate | This study is conducted in accordance with the ‘Helsinki Declaration’. Study protocol, patient information letter, and informed consent form were approved by an International Review Board Est-III (Nancy, Besançon, Dijon, Strasbourg, France) on October 3 | PMC10084642 | ||
Consent for publication | We will use our institutional consent form to confirm that we have obtained consent of the participant (or legal guardian) to report and publish individual patient data. We confirm that the images depicted in Figs. | PMC10084642 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10084642 | ||
References | PMC10084642 | |||
Background | COPD | DISEASE, COPD, VIRUS | Epstein-Barr virus (EBV) frequently is measured at high levels in COPD using sputum quantitative polymerase chain reaction, whereas airway immunohistochemistry analysis has shown EBV detection to be common in severe disease. | PMC10808072 |
Research Question | COPD, EBV suppression | COPD | Is valaciclovir safe and effective for EBV suppression in COPD? | PMC10808072 |
Study Design and Methods | COPD, Epstein-Barr Virus Suppression | ADVERSE REACTIONS, COPD | The Epstein-Barr Virus Suppression in COPD (EViSCO) trial was a randomized double-blind placebo-controlled trial conducted at the Mater Hospital Belfast, Northern Ireland. Eligible patients had stable moderate-to-severe COPD and sputum EBV (measured using quantitative polymerase chain reaction) and were assigned randomly (1:1) to valaciclovir (1 g tid) or matching placebo for 8 weeks. The primary efficacy outcome was sputum EBV suppression (defined as ≥ 90% sputum viral load reduction) at week 8. The primary safety outcome was the incidence of serious adverse reactions. Secondary outcome measures were FEV | PMC10808072 |
Results | EBV suppression | From November 2, 2018, through March 12, 2020, 84 patients were assigned randomly (n = 43 to valaciclovir). Eighty-one patients completed trial follow-up and were included in the intention-to-treat analysis of the primary outcome. A greater number of participants in the valaciclovir group achieved EBV suppression (n = 36 [87.8%] vs n = 17 [42.5%]; | PMC10808072 | |
Interpretation | COPD, EBV suppression | INFILTRATE, COPD | Valaciclovir is safe and effective for EBV suppression in COPD and may attenuate the sputum inflammatory cell infiltrate. The findings from the current study provide support for a larger trial to evaluate long-term clinical outcomes. | PMC10808072 |
Trial Registry | ClinicalTrials.gov; No.: NCT03699904; URL: | PMC10808072 | ||
Graphical Abstract | PMC10808072 | |||
Key Words | PMC10808072 | |||
Abbreviations | adverse eventEpstein-Barr virusinterquartile rangeNorthern Ireland Clinical Trials Unitquantitative polymerase chain reactiontertiary lymphoid organ
FOR EDITORIAL COMMENT, SEE | PMC10808072 | ||
Study Design and Methods | PMC10808072 | |||
Study Design and Patients | This was a randomized double-blind placebo-controlled allocation-concealed clinical trial conducted at Mater Hospital Belfast, Northern Ireland. Trial management, statistical support, and data monitoring and management was facilitated by the Northern Ireland Clinical Trials Unit (NICTU). The trial was sponsored by Belfast Health and Social Care Trust and received approval from the Office of Research Ethics Committees Northern Ireland (Identifier: 18/NI/0106). Clinical trial authorization was granted by Medicines and Healthcare Products Regulatory Agency. The study safety data were monitored every 6 months by an independent data monitoring and ethics committee. The trial was registered prospectively on EudraCT 2017-004686-28 and | PMC10808072 | ||
Randomization and Masking | Eligible participants were enrolled by the study investigators and assigned randomly (1:1) to valaciclovir 1 g tid or matching placebo for 8 weeks according to a prespecified randomization schedule. Mixed block sizes and no stratification were used. The randomization schedule was generated by an independent NICTU statistician using nQuery Advisor (Statsols). Both participants and investigators were masked to group assignment. Masking was achieved by gelatin encapsulation. Valaciclovir capsules contained valaciclovir tablets surrounded by microcrystalline cellulose, whereas placebo capsules contained microcrystalline cellulose only. Both valaciclovir and placebo capsules were identical. | PMC10808072 | ||
Procedures | exacerbations, COPD | ADVERSE EVENTS, CHRONIC OBSTRUCTIVE LUNG DISEASE, COPD | The trial involved a screening visit, a baseline visit (visit 1), and 8 weeks of double-blind treatment with valaciclovir (1 g tid for 8 weeks) or matching placebo with scheduled follow-up visits at week 4 (visit 2) and week 8 (visit 3). Participants continued with their allocated treatment schedule until they attended visit 3. A final follow-up phone call occurred at week 12 to assess adverse events (AEs) and exacerbations. The demographic and clinical details of each participant were recorded at the baseline visit. All study visits included detailed clinical assessment including documentation of medical history, medications, assessment of exacerbations, and sputum collection for quantification of EBV and exploratory outcomes. In accordance with Global Initiative for Chronic Obstructive Lung Disease recommendations, an exacerbation of COPD was defined as “an acute worsening of respiratory symptoms that results in additional therapy.” | PMC10808072 |
Outcomes | ADVERSE REACTIONS, SECONDARY | The primary efficacy outcome was the suppression of EBV in the sputum measured using qPCR between baseline and week 8. EBV suppression was defined as a 90% reduction in the viral load at week 8. The primary safety outcome was the incidence of serious adverse reactions. Prespecified secondary outcomes included the change in FEV | PMC10808072 | |
Sputum EBV Quantification and Biomarker Analysis | Nucleic acid was extracted from sputum specimens according to Regional Virus Laboratory Standard Operating Procedures. Full details of the sputum EBV quantification and sputum processing methods are provided in | PMC10808072 | ||
Sample Size | Using a χ | PMC10808072 | ||
Statistical Analysis | The primary efficacy outcome was analyzed on an intention-to-treat basis using a χContinuous outcomes were reported using mean ± SD, or median (interquartile range [IQR]) if appropriate, and treatment groups were compared using independent samples | PMC10808072 | ||
Results | cardiovascular comorbidity, COPD | VIRUS, SUPPRESSION, LUNG, EVENT, COPD, ADVERSE EVENT, REGRESSION, EVENTS | Between October 2018 and March 2020, 171 patients underwent trial screening. In total, 84 patients were assigned randomly to receive either valaciclovir (n = 43) or placebo (n = 41) (Consolidated Standards of Reporting Trials flow diagram showing the Epstein-Barr Virus Suppression in COPD Study: a randomized double-blind placebo-controlled trial. Baseline Patient Demographic and Clinical CharacteristicsData are presented as No. (%), mean ± SD, or median (IQR). EBV = Epstein-Barr virus; ICS = inhaled corticosteroid; IQR = interquartile range; LABA = long-acting β-agonist; LAMA = long-acting muscarinic antagonist; qPCR = quantitative polymerase chain reaction.Includes patients with at least one cardiovascular comorbidity.Primary Efficacy Outcome: Sputum EBV Suppression in the Intention-to-Treat Population (n = 81)Data are presented as No. (%), unless otherwise indicated. EBV = Epstein-Barr virus.Primary analysis.χLogistic regression.Adjusted analysis for FEVInteraction term.Boxplot showing baseline sputum EBV viral load and change from baseline to week 8. Error bars show the interquartile range. EBV = Epstein-Barr virus.Because of the initial COVID-19 national lockdown restrictions in the United Kingdom, the final 12 enrolled patients were unable to undergo lung function measurements at the end of treatment. Seventy patients had lung function measured at baseline and week 8 (Change in Lung Function From Baseline to Week 8 in Patients With Measurements at Both Time PointsData are presented as mean ± SD, unless otherwise indicated. Changes are calculated on the basis of available measurements for both time points. PEF = peak expiratory flow; TLCO = transfer factor for carbon monoxide.Independent samples Quality-of-life data were available for all 81 patients in the intention-to-treat population (A, B, Graphs showing effect of intervention on symptom scores and quality of life quantified at baseline, week 4, and week 8 using CAT (A) and EQ-5D-5L (B), respectively. CAT = COPD Assessment Test; VAS = visual analogue scale.The sputum total cell count was reduced significantly at week 8 in the valaciclovir group (difference, 2.9 × 10A-C, Boxplots showing baseline sputum biomarkers and mean change from baseline to week 8: sputum total cell count (A), IP-10 (B), and MCP-1 (C) quantified at baseline and at week 8 using trypan blue exclusion method and enzyme-linked immunosorbent assay, respectively. No safety concerns were identified during the conduct of the study, and the incidence of treatment-emergent AEs was comparable in both groups (Treatment-Emergent AEs in the Safety Population (n = 84)Data are presented as No. (%), unless otherwise indicated. A patient reporting more than one event in a category is counted only once. AE = adverse event; RR = relative risk.Those events with an incidence of ≥ 10% in either group.We conducted a post hoc analysis to examine the effect of sputum EBV suppression, regardless of treatment allocation, on change in FEV | PMC10808072 |
Discussion | herpes, COPD | INFILTRATE, HERPES, RECRUITMENT, ORAL HAIRY LEUKOPLAKIA, COPD, IDIOPATHIC PULMONARY FIBROSIS | In this randomized double-blind placebo-controlled trial of patients with moderate to severe COPD, valaciclovir was shown to be safe and effective for the suppression of EBV. We used valaciclovir at a dose of 1 g tid on the basis of a previous open-label study of oral hairy leukoplakia by Walling et al.This study was not designed to have adequate power to detect changes in lung function. However, we found a modest 24-mL numerical FEVOur finding that valaciclovir was associated with a reduction in the sputum total cell count may suggest attenuation of the sputum inflammatory cell infiltrate. The absolute neutrophil and macrophage counts were reduced by valaciclovir treatment (by > 50%), contributing to the significant treatment effect on the total cell count. One might hypothesize that persistent EBV shedding contributes to chronic airway immune activation and immune cell recruitment. However, it must be acknowledged that the current study did not demonstrate a definitive between-group difference in sputum cytokine concentrations, and any potential immunomodulatory mechanism of valaciclovir remains to elucidated. The six-fold within-group reduction in IP-10 may warrant further examination. Macrophages release IP-10, which is chemotactic for CD4Our study has some limitations. It is important to consider the spectrum of antiviral activity of valaciclovir. Polosukhin et alBeyond COPD, EBV and other herpes viruses have been targeted therapeutically in idiopathic pulmonary fibrosis. Blackwell et al | PMC10808072 |
Interpretation | COPD, EBV suppression | INFILTRATE, COPD | Valaciclovir is safe and effective for EBV suppression in COPD and may attenuate the sputum inflammatory cell infiltrate. The findings from the current study provide support for a larger trial to evaluate long-term clinical outcomes. | PMC10808072 |
Funding/Support | NICHS, Stroke | HEART, STROKE | This study was funded by the Mater Hospital YP Trustee Fund (registered with The Charity Commission for Northern Ireland [Identifier: NIC100084]). D. A. L. has received salary and research costs from Mater Hospital YP Trustees. M. C. M. reports funding from Medical Research Council (MRC) for current post [Grant MR/T016760/1] and previous doctoral study [Grant MR/P022847/1]. D. F. M. reports institutional grants from the UK National Institute for Health and Care Research (NIHR) and the Wellcome Trust. C. C. T. has received grants from MRC, NIHR, NICHS and Chiesi Farmaceutici. J. C. K. reports grants from Chest Heart and Stroke NI, NIHR, and Mater Hospital YP Trustees. | PMC10808072 |
Financial/Nonfinancial Disclosures | The authors have reported to | PMC10808072 | ||
References | PMC10808072 | |||
Supplementary Data | PMC10808072 | |||
e-Online Data | PMC10808072 | |||
Abstract | Principal Investigator: Jodi Layton, MD, Tulane School of Medicine, New Orleans, LA, USA | PMC10020796 | ||
Background | prostate cancer death, mCRPC, castrate-resistant prostate cancer | METASTATIC PROSTATE CANCER, CASTRATE-RESISTANT PROSTATE CANCER | Black men are at higher risk for prostate cancer death. Previous studies showed a benefit of different therapies, including immune-based therapy, for Black men with metastatic prostate cancer. We sought to explore the efficacy of the PD-L1 inhibitor avelumab in Black men with metastatic castrate-resistant prostate cancer (mCRPC) progressing after abiraterone or enzalutamide. | PMC10020796 |
Methods | PROSTATE | This pilot phase II study enrolled self-identified Black patients who developed mCRPC on next-generation hormonal therapies (NHTs) abiraterone acetate or enzalutamide (NCT03770455). Enrolled patients received avelumab 10mg/kg IV every 2 weeks while remaining on the same NHTs. The primary endpoint of our study was ≥ 50% reduction in prostate specific antigen (PSA) at ≥8 weeks. | PMC10020796 | |
Results | A total of eight patients were enrolled. The median duration on NHTs prior to enrollment was 364 days (95% CI, 260.9-467.1). The median time to initiate avelumab was 8 days (3-14). With a median follow-up of 196 days, no patients achieved the primary endpoint. The median time to PSA progression was 35 days (95 CI%, 0-94.8) and the median time to radiographic and/or clinical progression was 44 days (95 CI%, 0-118.5). The study was closed prematurely due to safety concerns related to the rapid clinical progression observed in the patients enrolled on study. | PMC10020796 | ||
Conclusion | castrate-resistant prostate cancer | METASTATIC PROSTATE CANCER, CASTRATE-RESISTANT PROSTATE CANCER | In conclusion, the addition of avelumab to NHT did not demonstrate clinical activity in Black men with new mCRPC. The unexpected short interval between PSA and radiographic and/or clinical progression observed in this study has potential clinical implications.ClinicalTrials.gov Identifier: NCT03770455 (IND number 139559).Previous studies have shown the benefit of immune-based therapies, such as sipuleucel-T, for Black men with metastatic prostate cancer. This study explored the efficacy of the PD-L1 inhibitor avelumab in Black men with metastatic castrate-resistant prostate cancer progressing after abiraterone or enzalutamide. | PMC10020796 |
Lessons Learned | mCRPC, castrate-resistant prostate cancer | CASTRATE-RESISTANT PROSTATE CANCER | The addition of avelumab did not demonstrate clinical activity in a cohort of Black men with metastatic castrate-resistant prostate cancer (mCRPC) that had progressed on abiraterone acetate or enzalutamide.Black men with mCRPC had a short interval between PSA and radiographic/clinical progression on this trial. | PMC10020796 |
Discussion | –10, tumor, prostatic tumors, prostate cancer | TUMOR, PROSTATE CANCER, MICROSATELLITE INSTABILITY | Our group and others have previously shown that immune checkpoint inhibitors are effective in specific prostatic tumors with microsatellite instability and high tumor mutational burden but their effect in the biology of prostate cancer is not entirely known.PSA kinetics of enrolled patients. The accelerated PSA progression after C1D1 compared with prior to C1D1 is represented by linear trend lines. PSA ratio was calculated by PSA at timepoint divided by PSA at day 0 (range, days –10 to 0).In both COU-AA-302 (abiraterone acetate) and PREVAIL (enzalutamide) which enrolled mainly Caucasian patients, the time interval between PSA progression and radiographic progression was approximately 5.3 and 5.1 months, respectively.As we expand clinical trial access and accrual to Black men, these results suggest that the interval between PSA and radiographic progression in Black men is likely to be short and thus more frequent radiographic monitoring might be necessary. Of note, this study was designed in the pre-PET scan era. Ongoing studies with PET imaging using fluciclovine or PSMA tracers (eg, NCT04158245) may offer an opportunity to improve response monitoring allowing for more effective and timely treatment decisions. | PMC10020796 |
Assessment, Analysis, and Discussion | prostatic malignancies, prostate cancer death, tumors, mCRPC, prostate cancer | ADVERSE EVENTS, DISEASE, SOLID TUMORS, SOMATIC MUTATION, EVENTS, TUMOR GROWTH, TUMORS, PROSTATE CANCER | Black men are known to be at higher risk for prostate cancer death.Black patients are continually underrepresented in clinical trials and there are possible racial differences in the molecular profiling of tumors and outcomes of these patients that require further investigation of active therapies in this underrepresented group.At the time of trial design, immune checkpoint inhibitors were being actively testing in several solid tumors and specific data on prostatic malignancies such as the phase III trial KEYNOTE-199 (NCT02787005) was not available. Results from KEYNOTE 199 published in 2019, showed the limited activity of immunotherapy unselected group of mCRPC patients, however distribution by race has not been reported.By the contrary, hyperprogression—defined as a paradoxical boost in tumor growth—has been observed in 4%-29% of solid tumors under treatment with immune checkpoint inhibitors.Our study did not require specific genomic alterations for eligibility, but molecular profiling was required at baseline for all patients. Notably, none of the enrolled patients had known immune-related markers that predict response to immune checkpoint inhibitors. One patient with a pathogenic somatic mutation in the homologous recombination repair gene FANCA had no response to avelumab, yet there is prostate cancer data suggesting other homologous recombination repair gene defects might be predictive of response to immune checkpoint inhibitors, but further validation is required.Critically, we were concerned at the number of serious adverse events experienced by this population, not related to treatment but with progression of their disease. Patients experienced clinical progression with serious events at a much more rapid rate than expected for men of their disease burden and stage of disease. Collectively, our group decided to close the study for safety concerns due to rapid progression of enrolled patients. Further investigation is necessary to confirm these racial differences and better inform the handling of treatment and expectations for Black men with mCRPC. | PMC10020796 |
Funding | EMD | We acknowledge that this study was financially supported by EMD Serono, Inc., an affiliate of Merck KGaA, in alliance with Pfizer Pharmaceuticals. | PMC10020796 | |
Conflict of Interest | OI |
(C/A) Consulting/advisory relationship; (RF) Research funding; (E) Employment; (ET) Expert testimony; (H) Honoraria received; (OI) Ownership interests; (IP) Intellectual property rights/inventor/patent holder; (SAB) Scientific advisory board. | PMC10020796 | |
Data Availability | The data underlying this article will be shared on reasonable request to the corresponding author. | PMC10020796 | ||
References | PMC10020796 | |||
Aim | EVENTS | We compared effects of infant positioning and feed‐rate interventions on respiratory events and oximetry parameters in spontaneously breathing preterm infants born <32 weeks gestation managed in a neonatal unit. | PMC10092656 | |
Methods | A randomised triple crossover design was employed. | PMC10092656 | ||
Results | EVENTS | Propped/prone positioning significantly reduced events and improved percentage time SpO | PMC10092656 | |
Conclusions | Alternative infant positioning should be considered in preterm infants managed in the neonatal unit.Conflict of interest: None declared. | PMC10092656 | ||
What is already known on this topic | EVENTS |
Cardiorespiratory events are common in preterm infants and reducing such events is a cornerstone of neonatal care.Position and feed‐rate interventions are frequently utilised without a clear evidence base.To our knowledge no studies have evaluated such interventions during or after feeds in spontaneously breathing infants prior to introduction of oral feeds. | PMC10092656 | |
What this paper adds | bradycardia, cot, apnoea | EVENTS, EVENT, APNOEA OF PREMATURITY |
This study evaluates the impact of feeding interventions (positional and feed‐rate) on cardiorespiratory events in spontaneously breathing preterm infants born <32 weeks gestation.Propped/prone positioning reduces events and improves oximetry profile compared with both neutral position and continuous pump feeds.Position interventions should be considered in developing neonatal care plans for the late preterm infant.Cardiorespiratory events are common in preterm infants and temporal relationships with feeding often prompt positional or feed‐rate interventions. Apnoea of prematurity is a pause in breathing of more than 15–20 s, with or without accompanying oxygen desaturation and/or bradycardia in infants born less than 37 weeks gestation.Prone positioning may improve cardiopulmonary stability and respiratory dynamicsA 2021 Cochrane systematic review examining pump versus gravity feeds identified a single small crossover trial, precluding meta‐analysis,This study evaluates the impact of feeding interventions (positional and feed‐rate) on respiratory event frequency in spontaneously breathing preterm infants born less than 32 weeks' gestation managed in a neonatal unit, prior to introduction of nutritive oral feeds. We evaluate whether alternative infant and cot positioning (supine vs. ‘propped and prone’) and slowing of feed‐rate (gravity feeds vs. pump) reduce frequency of apnoea and/or improve oximetry profiles. | PMC10092656 |
Methods | Randomised triple crossover design was employed whereby each infant underwent three test conditions in randomised sequence, each over a 24‐h period for three consecutive days without washout (Fig. (a) CONSORT flowchart and (b) conditions and sequences for randomised triple crossover design. | PMC10092656 | ||
Study population | congenital heart disease, congenital upper airway obstruction | EVENTS, RECRUITMENT, REFLUX | We recruited 68 preterm infants (birth gestation < 32 weeks) from an Australian tertiary neonatal unit. Eligible infants were: (i) self‐ventilating for at least 5 days prior to commencement; (ii) receiving full enteral feeds (>150 mL/kg/day) for at least 5 days and third‐hourly feeding for at least 48 h and (iii) not yet receiving formal nutritive oral/suck feeds. This group was selected to minimise confounding variables, such as changes to ventilatory parameters or enteral feed volumes during the study period. Infants receiving low‐flow sub‐nasal oxygen (<0.5 L/min) were eligible provided other respiratory criteria were met. Infants receiving caffeine citrate were included; however, dose was only adjusted for body weight during the trial period. Infants receiving nutritive oral feeds (counted towards daily fluid quota) were excluded as breast/bottle‐feeding precluded control of test conditions. All infants meeting criteria were considered for recruitment, irrespective of baseline respiratory events.Infants with significant comorbidities were excluded, including those that might preclude alternative positioning (surgical indications, symptomatic congenital heart disease) or confound interpretation of outcome measures (congenital upper airway obstruction, pharmacotherapy for gastro‐oesophageal reflux). Additional exclusion criteria included palliative care redirection or imminent discharge/transfer. | PMC10092656 |
Outcome measures | EVENTS, EVENT, EVENTS | Primary study outcomes were: (i) number of respiratory events and (ii) percentage of time with SpOManual review of event triggers was undertaken by four investigators who were blinded to the condition sequence using standardised data collection sheets. Events were reconciled with dedicated nursing observation records and counted based on clinical assessment. Oximetry histogram generation by the monitoring system occurred at the conclusion of each 24‐h study period.Baseline demographic data were recorded including gender, twin status, gestational age and weight (birth and commencement), caffeine administration and supplemental oxygen to describe our cohort. Data were recorded in an encrypted Microsoft Excel spreadsheet. | PMC10092656 | |
Position intervention | cot | Infants undertaking Condition A (‘supine and flat’) were placed supine with the cot in neutral (horizontal) position. The positional intervention, Condition B (‘propped and prone’), combined infant and cot position, with infants placed prone with head turned to one side and cot inclined at 15° (default cot elevation achievable within the unit). Positioning during Conditions A and B was maintained as default position throughout each 24‐h test period, but allowed for position change for routine nursing and medical care. Parent handling (holding and skin‐to‐skin) was encouraged, however avoided during and within 1 h of feeding. | PMC10092656 | |
Infants in Conditions A and B received usual third‐hourly gravity bolus feeds via nasogastric tube, typically over 5–15 min. The feed‐rate intervention (Condition C) was defined by third‐hourly feed volume given over 45 min by pump, with usual supine/flat infant position. Pump feeds were administered via Vygon (Écouen, France) Nutrisafe‐2 pump and giving set. | PMC10092656 | |||
Sample size | EVENTS | We aimed to recruit 90 infants to detect a 40% reduction in the log(number of events) and a 50% reduction in the log(percentage time with SpO | PMC10092656 | |
Statistical analysis | APPENDIX | Additional statistical methodology is provided in Appendix | PMC10092656 | |
Results | PMC10092656 | |||
Baseline participant characteristics | EVENTS | Of 68 infants included in the study, 23 (34%) were twins and 38 (56%) were male (Table Patient characteristics; overall and by treatment sequence (Pair of twins allocated to same condition sequence.Ten data points were missing for daily number of events (5%) and there were four missing data points each for time SpO | PMC10092656 | |
Outcomes | EVENTS, EVENT | Condition B (positional intervention) demonstrated lower number of events, smaller percentage time with SpOMarginal mean estimates for number of events, percentage of time spent with SpO
Back transformed estimates and 95% CIs.There was a statistically significant increase in percentage time with SpODescriptive statistics for event frequency and oximetry by day and sequence are given in Table Box plots of (a) number of events (b) logit transformed percentage of time with peripheral oxygen saturation less than 80% and (c) logit transformed percentage of time spent with peripheral oxygen saturation 88% or more; presented in treatment order of (a), (b) and (c) for each sequence. The first letter in the treatment sequence corresponds to the treatment on day 1, the second letter treatment on day 2 and the third letter on day 3.No carryover effect was present in any models evaluated. Two outliers (StudyID 20, day 1 and StudyID 52, day 2) were present in sequence BAC for number of events, identified on scatterplot of deviance by treatment sequence; however, these were not present on Pearson plots and their exclusion did not significantly change treatment estimates or between‐infant variance. The relationships and size of effects did not change when LMM was run using the log(number of events) compared to (GL(M)M). Similar results were obtained for both miTT and PP data sets for all outcomes (Tables | PMC10092656 | |
Summary | EVENTS | The positional intervention (Condition B) was superior compared to other conditions, significantly reducing number of events and percentage of time with SpO | PMC10092656 | |
Discussion | EVENTS, SECONDARY | ‘Propped and prone’ positioning is superior to both supine/flat positioning and continuous pump‐feeding in reducing respiratory events and percentage time with SpOThere were no differences in primary or secondary outcomes between feed‐rate intervention (continuous pump‐feeds) and care‐as‐usual (gravity bolus feeds). This result is consistent with previous limited reviews | PMC10092656 | |
Limitations | cot | RECRUITMENT, SENSITIVITY, SECONDARY, SEPARATION, SUDDEN INFANT DEATH SYNDROME, EVENTS | There was <5% missing data for primary and secondary outcomes, some missing at random and some not. The sequence effect in the events model is thought to be due to patient characteristics. Sensitivity analysis showed results are robust and confirm Condition B as superior.Our position intervention combined both infant and cot position, as these typically occur together and their separation would complicate crossover design. Further study is required to evaluate any separate contributions. Prone positioning improves quiet sleep, which is known to positively impact frequency of respiratory events.Additionally, infants undertook interventions for the entire 24‐h period. Developmental implications of this approach require further evaluation, and additional studies could evaluate if interventions during feed times only might preserve this effect. This study targeted ‘stable, growing’ spontaneously breathing preterm infants (mean gestation of 34.6 weeks). Results may not, therefore, be applicable to younger infants or those receiving additional respiratory supports. These findings may also conflict with recommendations to promote supine positioning as infants approach discharge to reduce the incidence of Sudden Infant Death Syndrome and must therefore consider individual infant factors and disposition planning.Our proposed sample size was not achieved for a number of reasons, most importantly premature cessation of the study to the Covid‐19 pandemic. Recruitment was additionally impacted by unexpectedly short eligibility windows between cessation of respiratory support and oral‐feed introduction. We observed, however, smaller between‐ and within‐subject variances and an increased percent reduction in number of events than predicted by the pilot (50% compared with 40% from the pilot). Post hoc power analyses showed an | PMC10092656 |
Conclusions | EVENTS | Propped and prone positioning should be considered by neonatal physicians and nurses caring for spontaneously breathing, late‐preterm infants with established enteral feeds, particularly those in whom respiratory events have been problematic. There does not appear to be evidence to support feed‐rate interventions in this group for this indication. Individual consideration must necessarily be given to infant factors, nursing cares, medical interventions and parental preference. Position interventions must also be balanced with safe sleeping considerations as infants approach hospital discharge. Although it is not feasible to maintain a single infant position for all cares and interventions, neonatal units might consider prioritisation of propped/prone positioning in developing infant care plans. Larger, multi‐centre studies are required to further evaluate this effect and permit further subgroup analyses. | PMC10092656 | |
Author Contributions | Conceptualization & Methodology: Christopher M Richmond and Pita Birch; Data Collection: Christopher M Richmond, Fabian Ring, Lacey Richmond, and Erika Rossouw, Formal Analysis: Christopher M Richmond and Emma Ballard; Validation: Christopher M Richmond, Emma Ballard, Pita Birch; Supervision: Pita Birch; Writing, original draft: Christopher M Richmond, and Emma Ballard; Writing, review & editing: Christopher M Richmond, Fabian Ring, Lacey Richmond, Erika Rossouw, Emma Ballard, and Pita Birch. | PMC10092656 | ||
Ethics Statement | This project received Human Research Ethics Committee approval (HREC/15/QGC/297) and site‐specific approval (SSA/15/QGC/300) through Gold Coast Health (Southport, Queensland, Australia) in 2016. | PMC10092656 | ||
Supporting information |
Click here for additional data file. | PMC10092656 | ||
Acknowledgements | The authors wish to acknowledge and value the contributions of clinical staff who supported the trial within the Newborn Care Unit at Gold Coast University Hospital, Statisticians at Data Analysis Australia for initial advice on study design and families who contributed their time to this study. Open access publishing facilitated by Griffith University, as part of the Wiley ‐ Griffith University agreement via the Council of Australian University Librarians. | PMC10092656 | ||
Data Availability Statement | Data analysed are supplied in Supporting Information and are also available upon request to the corresponding authors. | PMC10092656 | ||
References | PMC10092656 | |||
Objectives | ’ | Jumping ability has been identified as a key factor that influences the performance of badminton athletes. Autoregulatory progressive resistance exercise (APRE) and velocity-based resistance training (VBRT) are commonly used approaches to enhance muscle strength and have been shown to accurately monitor the development of explosive power to improve jumping ability. This study aims to investigate the effects of APRE and VBRT on badminton athletes’ jumping ability and to provide practical insights into improving their jumping performance during competitions. | PMC10414022 | |
Methods | ± | Upon completing familiarization and pretesting, 18 badminton athletes were included and completed the training intervention (age, 21.4 ± 1.4 years; stature, 170.1 ± 7.3 cm; body mass, 65.9 ± 12 kg); they were randomly divided into the APRE group ( | PMC10414022 | |
Results | (1) The results of the within-group indicated that only the CMJ (pre: 41.56 ± 7.84 | PMC10414022 | ||
Conclusions | ’ lower limb explosive | The results showed that, compared to VBRT, APRE can effectively improve the performance of the reactive athletes’ lower limb explosive power in the CMJ in a shorter period of time. The findings indicate that APRE may be useful for coaches seeking to improve the CMJ performance of athletes in the short term. | PMC10414022 | |
Introduction | RPE | Badminton is a type of racquet sport that involves various explosive movements, such as jumping, quick changes of direction, net shots, and fast arm movements (Autoregulatory progressive resistance exercise (APRE), rating of perceived exertion (RPE), and velocity-based resistance training (VBRT) are three common methods of ART (In the field of ART, attention has been focused on comparing APRE with PBT (here, PBT refers to linear periodized percentage-based resistance training, and all studies on APRE in this article used this definition of PBT), VBRT with PBT, VBRT with RPE, and different velocity losses ( | PMC10414022 | |
Materials and Methods | PMC10414022 | |||
Experimental approach to the problem | A randomized controlled trial was conducted to investigate the effects of APRE and VBRT on the explosive power of the lower limbs in athletes. After familiarization with the program and pretesting, participants were randomly assigned to the VBRT or APRE group. Participants volunteered to participate in the study from April 2022 to June 2022. The experimental period lasted for 6 weeks, including the first and last weeks of testing, in which all participants completed two training sessions per week for 4 weeks. Testing consisted of countermovement jump (CMJ), squat jump (SJ), and drop jump (DJ) tests. All tests were performed at least 48 h before/after the most recent training session. All testing and training sessions took place at the same venue under the direct supervision of the lead investigator. | PMC10414022 | ||
Participants | ±, injury or illness | Twenty-one participants (male = 11, female = 10) were originally recruited to take part in the research study. The inclusion criteria of the recruited athletes for the study were as follows: (1) absence of any significant physical health issues, (2) older than 18 years, (3) a minimum of 3 years of prior experience in playing badminton, and (4) absence of any injury or illness in the past 6 months. However, three participants were excluded due to injury, so only 18 badminton athletes were included and completed the training intervention (age, 21.4 ± 1.4 years; stature, 170.1 ± 7.3 cm; body mass, 65.9 ± 12 kg). The participants were randomly distributed into two groups: VBRT ( | PMC10414022 | |
Physical characteristics of the participants (M ± SD). | PMC10414022 | |||
Procedures | Participants completed jumping performance testing in 1 day, including the CMJ, SJ, and DJ. Before all testing and training sessions, participants were supervised during a standardized warm-up, consisting of 5 min of jogging and dynamic stretching. After the completion of the final resistance training, testing for outcome measures was repeated after 48 h of recovery. | PMC10414022 | ||
Outcome measures | BEND | CMJ, SJ, and DJ tests were administered indoors using the SmartJump wireless portable jump test mat, which consists of a wireless mobile device terminal and a SmartJump vertical jump mat. The jumping test mat analyzes the jumping motion by pressure sensing. All the tests required participants to place their arms around their waist and not bend their hips and knees during the lift-off process. For the CMJ, participants kept their torso as immobile as possible while simply completing a coherent and rapid squat jump to the maximum height. For the SJ, participants listened to the experimenter’s command; after the participants hear “squat,” they perform a half squat; the experimenter says “1, 2,” and then “jump,” and the participants quickly jump to their maximum height. For the DJ, participants stepped off a box (height, 30 cm) with their preferred leg, landed on the floor with both feet, and immediately jumped as high as possible. Participants were instructed to jump to the highest height as fast as possible. The CMJ, SJ, and DJ were performed three times with 20-s rests between each jump, with the highest jump (in centimeters), eccentric utilization ratio (CMJ’s jump height (in centimeters)/SJ’s jump height (in centimeters)), and reactive strength index (jump height (in meters)/contact time (in seconds)) used for analysis. | PMC10414022 | |
Statistical analyses | Data analysis was completed using Jamovi 2.3.26. Mean and standard deviation (SD) values were calculated using standard statistical methods. The normality of all variables was tested using the Shapiro–Wilk test procedure. Levene’s test was used to determine the homogeneity of variance. Subsequently, repeated measures analysis of variance was performed. The differences between the groups before and after training and the differences in change scores between the two groups before and after training were compared. The Bonferroni adjustment was performed to determine the | PMC10414022 | ||
Results | ± | All data are expressed as means ± SD. The subject’s characteristics including age, weight, and height are listed in After 4 weeks of training, only the APRE group demonstrated greater improvement in the CMJ (pre: 41.56 ± 7.84 | PMC10414022 | |
Intra-group and inter-group change in CMJ, SJ, EUR, and RSI from 4 week for APRE and VBRT groups. | All data are presented as Mean ± SD. *Significant differences between pre- and post- for APRE or VBRT at the | PMC10414022 | ||
Changes in the variables of CMJ, SJ, EUR, and RSI between pre- and post-test after training in each of groups. | PMC10414022 | |||
Conclusion | RSI | Improving the jumping ability of badminton athletes is crucial for achieving excellent athletic performance and competition results. Therefore, coaches need to understand methods for enhancing the jumping ability of athletes during the season. This study found that using APRE can effectively improve the CMJ performance of badminton athletes in a shorter period and that APRE is superior to VBRT in terms of CMJ performance and EUR testing. From a practical perspective, APRE was associated with greater power and neuroadaptation, as well as similar repetitions and total training volume, throughout a 4-week training cycle when compared with VBRT. Therefore, APRE may assist coaches in enhancing the CMJ performance of athletes in the short term, whereas improvements in the SJ performance, EUR, and RSI may require longer-term training intervention to manifest. | PMC10414022 | |
Supplemental Information | PMC10414022 | |||
Experimental program. | Click here for additional data file. | PMC10414022 | ||
Experimental data. | Click here for additional data file.We would like to thank the researchers and study participants for their contributions. | PMC10414022 | ||
Additional Information and Declarations | PMC10414022 | |||
Competing Interests | The authors declare that they have no competing interests. | PMC10414022 | ||
Human Ethics | The following information was supplied relating to ethical approvals (This study was approved by the Ethics Committee for Human Experiments (Approval number: 2022LCLL-38). | PMC10414022 | ||
Data Availability | The following information was supplied regarding data availability:Raw data are available in the | PMC10414022 | ||
References | PMC10414022 | |||
Introduction | death, urinary tract infections, bacterial infection, infections, bacteriuria, sepsis, UTIs | INFECTIOUS DISEASES, SYSTEMIC DISEASE, URINARY TRACT INFECTIONS, URINARY TRACT INFECTIONS, BACTERIAL INFECTION, INFECTIONS, NOSOCOMIAL INFECTIONS, UTI, SEPSIS | Urinary tract infections (UTIs) are among the most prevalent infectious diseases in both community and healthcare settings [Among hospital settings, UTIs account for almost 40% of all nosocomial infections, and represent a major burden, given the associated morbidity and mortality. A correlation between urinary tract infections and systemic diseases has been recently suggested as patients displaying bacteriuria due to drug-resistant pathogens are more prone to develop sepsis, often due to treatment failure [The emergence of antimicrobial resistance (AMR) is a major public health challenge that is threatening the effective prevention and treatment of an ever-increasing range of infections. Mortality rates associated to drug-resistant microorganisms are expected to rise in the next decades. As stated by the National Institute for Health and Care Excellence (NICE), by 30 years up to 10 million people could be under death threat due to unsuccessful antibiotic treatment [Uropathogens vary from the community to the hospital setting, with different main agents prevailing and higher AMR frequencies in the latter; this causes a greater difficulty to achieve successful treatment, associated with longer hospitalization, patient’s uneasiness and overall higher costs [Suspected UTIs are commonly treated with antibiotics, and guidelines recommend starting an empirical treatment before the results of urine culture and AST are available [In this context, the importance of using evidence-based strategies for the treatment of UTI becomes undeniable: a fast and accurate diagnosis, leading to a rational treatment, is in fact essential to provide a timely and successful therapy.The National Institute of Clinical Excellence has long been demanding the improvement and implementation of urine testing seeking for markers of bacterial infection in order to avoid empiric treatment for suspected UTIs [In this context, Point of care Tests (POCTs) for UTI diagnosis, where testing is provided close to or near the patient, are currently being studied; their implementation in routine practice could facilitate the screening of UTIs, allow prompt treatment only when needed, and ultimately optimize workflows in order to reduce the burden on central laboratories, allow adherence to guidelines and improve therapeutical outcomes [In a previous paper we described a new POCT for UTI detection upon culture of urine samples based on the Micro Biological Survey method. This POCT demonstrated to be accurate and time saving: performed in ready to use, disposable reaction vials and based on the time taken for the reaction vials to change color. It allows a quantitative assessment in of viable bacteria concentration in urine samples in less than 5 hours, not needing other instrumentation than a dedicated thermostatic reader which automatically provides results, opening for automation and processing of multiple samples [Here, the proficiency of the MBS AST-POCT was tested in two trials conducted between 2015 and 2017 in two clinical Departments differing in demographic and clinical profile of cared patients, in order to achieve a broader and realistic assessment of the performances of the AST-POCT in both community and hospital settings. | PMC10321614 |
Material and methods | PMC10321614 | |||
Study design | EMERGENCY, UTI | A total of 349 patients were enrolled in two open-label, monocentric, non-interventional clinical trials in collaboration with the Department of Emergency Medicine at Azienda Ospedaliera Sant’Andrea, Rome and the outpatient clinic at Istituto Dermopatico dell’Immacolata, Rome; 101 and 248 patients were enrolled in the two facilities, respectively, between November 2015 and December 2017. Prior to study participation, each patient was asked to read carefully through the patient information sheet and signed the informed consent. Approval of the study was obtained on 14.01.2013 from the Ethical Committee of Azienda Ospedaliera Sant’Andrea, and on 25.05.2017 from the Ethical Committee of Istituto Dermopatico dell’Immacolata, constituted according to DM 12.05.2006 following Good Clinical Practice. Authorization was given based on the declaration that the patients were duly informed and consenting. Only patients subscribing the informed consent were enrolled. The clinical trial did not imply any change in the normal diagnostic and therapeutic procedures.Among patients enrolled in the two studies, AST was carried out on a total of 97 patients diagnosed with UTI upon urine culture, after admission in the health care facilities. | PMC10321614 |
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