Contemporary Clinical Trials Communications最新文献

{"title":"Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial)","authors":"Callin Chetty ,&nbsp;Nomfuneko Mafunda ,&nbsp;Anna-Ursula Happel ,&nbsp;Anam Khan ,&nbsp;Briah Cooley Demidkina ,&nbsp;Nonhlanhla Yende-Zuma ,&nbsp;Yusra Saidi ,&nbsp;Asthu Mahabeer Polliah ,&nbsp;Lara Lewis ,&nbsp;Farzana Osman ,&nbsp;Precious Radebe ,&nbsp;Jo-Ann S. Passmore ,&nbsp;Doug Kwon ,&nbsp;Jacques Ravel ,&nbsp;Sinaye Ngcapu ,&nbsp;Lenine Liebenberg ,&nbsp;Laura Symul ,&nbsp;Susan Holmes ,&nbsp;Caroline M. Mitchell ,&nbsp;Disebo Potloane","doi":"10.1016/j.conctc.2025.101554","DOIUrl":"10.1016/j.conctc.2025.101554","url":null,"abstract":"<div><h3>Background</h3><div>Globally, approximately 30 % of women have bacterial vaginosis (BV). Antibiotic treatment is frequently followed by recurrence, likely due to lack of colonization with beneficial lactobacilli.</div></div><div><h3>Methods</h3><div>This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish <em>Lactobacillus</em> colonization. The LBP are vaginal tablets containing 6 <em>L. crispatus</em> strains (LC106) or 15 <em>L. crispatus</em> strains (LC115), at 2 x 10⁹ colony forming units (CFU) per dose. Participants with BV in the United States and South Africa will receive seven days of oral metronidazole twice daily and will be randomized 1:1:1:1:1 to: seven days placebo; seven days LC106; three days LC106/four days placebo; seven days LC106 starting day 3 of the metronidazole course; or seven days LC115. Safety will be assessed by the number and percentage of ≥ Grade 2 related adverse events during or after product use. The primary outcome is LBP colonization defined as relative abundance ≥5 % of any LBP strain or ≥10 % of a combination of LBP strains by metagenomic sequencing any time in the 5 weeks after randomization. A generalized linear model will measure the association between treatment group and colonization, adjusting for site.</div></div><div><h3>Conclusions</h3><div>This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal <em>L. crispatus</em> colonization in two geographically distinct populations.</div></div><div><h3>Trial registration</h3><div>South African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 11, 2023).</div></div><div><h3>Protocol version</h3><div>2.0 dated October 03, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101554"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults","authors":"Selenia Rubio ,&nbsp;Patricia Cabrera ,&nbsp;Rory Reever ,&nbsp;Cesar Migliorati ,&nbsp;Richard Ohrbach ,&nbsp;Frank C. Gibson III ,&nbsp;Zhigang Li ,&nbsp;Angela Mickle ,&nbsp;Rosalynn R.Z. Conic ,&nbsp;Roger B. Fillingim ,&nbsp;Margarete Ribeiro Dasilva","doi":"10.1016/j.conctc.2025.101571","DOIUrl":"10.1016/j.conctc.2025.101571","url":null,"abstract":"<div><div>Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response.</div></div><div><h3>Clinicaltrials.gov identifier</h3><div>NCT05916235</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101571"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3","authors":"Florian Wagenlehner ,&nbsp;Keith S. Kaye ,&nbsp;David A. Talan ,&nbsp;Amanda J. Sheets ,&nbsp;Nicole E. Scangarella-Oman ,&nbsp;Emily Jarvis ,&nbsp;Jeremy Dennison ,&nbsp;Salim Janmohamed ,&nbsp;Matthew Helgeson ,&nbsp;Caroline Perry","doi":"10.1016/j.conctc.2025.101572","DOIUrl":"10.1016/j.conctc.2025.101572","url":null,"abstract":"<div><h3>Aim</h3><div>To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.</div></div><div><h3>Methods</h3><div>EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥10⁵ colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.</div></div><div><h3>Results</h3><div>Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).</div></div><div><h3>Conclusion</h3><div>Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.</div><div>The trials are registered at <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101572"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease","authors":"Silvio Danese ,&nbsp;Bruce E. Sands ,&nbsp;Brian G. Feagan ,&nbsp;Vipul Jairath ,&nbsp;Remo Panaccione ,&nbsp;Laurent Peyrin-Biroulet ,&nbsp;Peter M. Irving ,&nbsp;Stefan Schreiber ,&nbsp;Iris Dotan ,&nbsp;Marc Ferrante ,&nbsp;Geert R. D'Haens ,&nbsp;Stephen Jones ,&nbsp;Marcelo Freire ,&nbsp;Dirk Lindner ,&nbsp;Shashi Adsul ,&nbsp;Pooja Oberai ,&nbsp;Jean-Frédéric Colombel","doi":"10.1016/j.conctc.2025.101574","DOIUrl":"10.1016/j.conctc.2025.101574","url":null,"abstract":"<div><h3>Introduction</h3><div>Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.</div></div><div><h3>Methods</h3><div>The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.</div></div><div><h3>Conclusion</h3><div>VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.</div></div><div><h3>Clinical trials registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT06227910.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101574"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study","authors":"Yosef Sokol ,&nbsp;Sofie Glatt ,&nbsp;Sarah Andrusier ,&nbsp;Chynna Levin ,&nbsp;Caroline Boucher ,&nbsp;Josephine Ridley ,&nbsp;Clayton H. Brown ,&nbsp;Yulia Landa ,&nbsp;Shirley Glynn ,&nbsp;Marianne Goodman","doi":"10.1016/j.conctc.2025.101576","DOIUrl":"10.1016/j.conctc.2025.101576","url":null,"abstract":"<div><h3>Introduction</h3><div>There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.</div></div><div><h3>Method</h3><div>Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.</div></div><div><h3>Results</h3><div>CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.</div></div><div><h3>Discussion</h3><div>The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.</div></div><div><h3>Clinical trial registration</h3><div>NCT04731519.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101576"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial” [Contempor. Clinic. Trial. Commun. 47 (2025) 101537]","authors":"Eric C. Meyer ,&nbsp;Todd Farchione ,&nbsp;Nathan A. Kimbrel ,&nbsp;Oi-Man Kwok ,&nbsp;Michelle L. Pennington ,&nbsp;Jessica Rostockyj ,&nbsp;Suzy B. Gulliver","doi":"10.1016/j.conctc.2025.101568","DOIUrl":"10.1016/j.conctc.2025.101568","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101568"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unmasking three blinding indices for randomized controlled trials: comparison and application","authors":"Javier Muñoz Laguna ,&nbsp;Jafar Kolahi ,&nbsp;Heejung Bang","doi":"10.1016/j.conctc.2025.101553","DOIUrl":"10.1016/j.conctc.2025.101553","url":null,"abstract":"<div><div>Blinding is an important methodological aspect of randomized controlled trials. Although three blinding indices are available for the estimation of blinding in clinical trials, little guidance is available regarding their comparison and application. Here, we compared three blinding indices and applied them to hypothetical and real-world clinical trial data. Through this comparison and application tutorial, we identified strengths and limitations of each blinding index. Our findings provide insights into the assessment, estimation and reporting of blinding in randomized controlled trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101553"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145268553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What works for men? Participant perspectives from a mixed-gender weight-management trial with incentives","authors":"Katya Garza ,&nbsp;Hisham Ahmad ,&nbsp;Bhabna Pati ,&nbsp;Corrine I. Voils","doi":"10.1016/j.conctc.2025.101570","DOIUrl":"10.1016/j.conctc.2025.101570","url":null,"abstract":"<div><h3>Background</h3><div>Men are underrepresented in behavioral weight-loss trials, limiting the generalizability of findings. While gender-tailored programs have shown success, most research and community-based weight management programs remain mixed-gender. Little is known about men's experiences in these settings or how to best adapt mixed-gender programs to improve their relevance to men.</div></div><div><h3>Purpose</h3><div>To explore men's experiences regarding weight management and to qualitatively evaluate their experiences in the Log2Lose trial.</div></div><div><h3>Methods</h3><div>Semi-structured interviews were conducted with men who participated in the Log2Lose trial, a randomized study evaluating the effects of financial incentives on weight loss. Interviews explored motivations for enrolling, satisfaction with program components, and suggestions for improvement. Data were analyzed using conventional content analysis.</div></div><div><h3>Results</h3><div>Nineteen men completed interviews. Most self-identified as White, were middle-aged, married, and college educated. Six themes emerged: 1) Prior weight loss efforts were self-directed and hard to sustain; 2) Rising health concerns prompted men to seek support; 3) Higher-engagers framed weight loss as a personal responsibility, whereas lower-engagers preferred more external accountability; 4) Traditional social roles influenced dietary changes; 5) Peer relatability defined group experiences more than gender composition; 6) Men valued practical content but wanted more tailored support.</div></div><div><h3>Conclusions</h3><div>Men valued their participation in the Log2Lose trial and identified ways to improve relevance and engagement. This study provides participant-informed guidance to support the development of mixed-gender behavioral interventions that appeal to men and promote more equitable representation in weight loss research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101570"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145578716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury","authors":"Mohammod Mahmudur Rahman ,&nbsp;Md Saiful Islam Saif ,&nbsp;Jonathan Beall ,&nbsp;Renee’ L. Martin ,&nbsp;Gaylan L. Rockswold ,&nbsp;William G. Barsan ,&nbsp;Frederick K. Korley ,&nbsp;Robert Silbergleit ,&nbsp;Valerie Stevenson ,&nbsp;Byron Gajewski","doi":"10.1016/j.conctc.2025.101586","DOIUrl":"10.1016/j.conctc.2025.101586","url":null,"abstract":"<div><h3>Background</h3><div>Accurate accrual prediction is essential for initial planning and ongoing monitoring of clinical trials. Slow accrual can compromise statistical power, increase costs, or lead to premature trial termination. Traditional Bayesian approaches typically assume constant accrual rates and often fail to capture real-world seasonal fluctuations, which can reduce predictive accuracy.</div></div><div><h3>Methods</h3><div>We developed a Bayesian seasonal accrual model that extends the traditional homogeneous model by incorporating quarter-specific priors to account for seasonal variation. The model combines prior knowledge with observed data up to the monitoring point to obtain accrual predictions using the Bayesian posterior predictive distribution. We applied this approach to quarterly accrual data from two ongoing trials: the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial and the Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3) trial. Along with the Deviance Information Criterion, model performance was evaluated using RMSE, bias, and standard deviation, calculated from internal predictions of total accruals within observed seasonal quarters. Posterior predictive distributions of accrual after 36 and 30 quarters were also generated.</div></div><div><h3>Results</h3><div>Both trials exhibited seasonal trends, with the highest accrual rates in summer. The seasonal model yielded lower DIC in both trials. In HOBIT, internal prediction accuracy did not improve, likely due to uniformly low accrual rates. In contrast, the seasonal model outperformed the homogeneous model in BOOST-3 trial, yielding substantially lower RMSE, bias, and SD.</div></div><div><h3>Conclusion</h3><div>Incorporating seasonal effects into accrual modeling can enhance prediction accuracy, particularly in larger trials with high enrollment, and supports more accurate trial forecasting and resource allocation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101586"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial","authors":"Samantha A. Lee ,&nbsp;Diego Trujillo ,&nbsp;Garth D. Meckler ,&nbsp;Carl Eriksson ,&nbsp;Trang Huynh ,&nbsp;Nathan Bahr ,&nbsp;Jyotsna Sanjeevi ,&nbsp;Matt Hansen ,&nbsp;Jeanne-Marie Guise","doi":"10.1016/j.conctc.2025.101558","DOIUrl":"10.1016/j.conctc.2025.101558","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).</div></div><div><h3>Objective</h3><div>This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.</div></div><div><h3>Study design</h3><div>This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.</div></div><div><h3>Main outcome measures</h3><div>Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.^1,2</div></div><div><h3>Conclusion</h3><div>We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.</div></div><div><h3>Trial Registration Number</h3><div>NCT06768099 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101558"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}