Contemporary Clinical Trials Communications最新文献

{"title":"Novel approach for oligospermia (NAPO) - Protocol for a randomized controlled trial","authors":"Sam Kafai Yahyavi ,&nbsp;Mads Joon Jorsal ,&nbsp;Rune Holt ,&nbsp;Bugge Nøhr ,&nbsp;Martin Blomberg Jensen","doi":"10.1016/j.conctc.2024.101352","DOIUrl":"10.1016/j.conctc.2024.101352","url":null,"abstract":"<div><h3>Background</h3><p>Infertility affects millions of couples globally, with up to 40–50 % of cases linked to impaired semen quality. Insemination or in vitro fertilization are used frequently, regardless of the cause of infertility due to the lack of specific medical interventions for male infertility. Denosumab, an antibody blocking RANKL signaling, may enhance semen quality in infertile men. This randomized controlled trial evaluates if denosumab improves spermatogenesis in men with severely impaired semen quality identified by serum AMH levels as a predictive marker.</p></div><div><h3>Methods</h3><p>NAPO is a single-center, sponsor-investigator-initiated, placebo-controlled, double-blinded randomized trial. Subjects will be randomized in a 2:1 fashion to receive either denosumab 60 mg subcutaneously or a placebo. The study will be carried out at the Division of Translational Endocrinology, Copenhagen University Hospital, Herlev, Denmark. The primary outcome of the study is defined as the difference in sperm concentration (millions/mL) at one spermatogenesis (80 days) after inclusion.</p></div><div><h3>Discussion</h3><p>An important step in addressing infertility is establishing a viable treatment option for male infertility. With this study, we describe the protocol for a planned RCT aimed at evaluating whether treatment with denosumab can improve sperm concentration in men with severely impaired semen quality. The results of this study will provide evidence crucial for future treatment in a patient group where treatment options are minimal at best.</p></div><div><h3>Trial registration</h3><p>Clinical Trials: NCT06300229. Registered on March 12, 2024. Clinical Trials Information System (CTIS): 2023-508325-27-00. Approved on December 19, 2023.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101352"},"PeriodicalIF":1.4,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000991/pdfft?md5=9503e5920cc2499e0c3eab87f581b38c&pid=1-s2.0-S2451865424000991-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142076955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of traditional Chinese manual therapy for cervicogenic dizziness: study protocol for a randomized, controlled, multicenter trial","authors":"Yunfan Zhan ,&nbsp;Yujie Zhang ,&nbsp;Kaoqiang Liu ,&nbsp;Ye Zhao ,&nbsp;Jiawei Ning ,&nbsp;Yongli Chai ,&nbsp;Lingjun Kong ,&nbsp;Weian Yuan","doi":"10.1016/j.conctc.2024.101349","DOIUrl":"10.1016/j.conctc.2024.101349","url":null,"abstract":"<div><h3>Background</h3><p>Cervicogenic dizziness is a clinical syndrome characterized by neck pain and dizziness, which has a rising incidence in recent years. In China, manual therapy has been widely used in the treatment of cervicogenic dizziness, but there is no high-quality medical evidence to support its effectiveness and safety. The purpose of this study was to assess the safety and efficacy of Shi's manual therapy (SMT) on the treatment of cervicogenic dizziness.</p></div><div><h3>Methods</h3><p>A multicenter randomized controlled trial (RCT) will perform on 106 patients (18≤ages≤65) who meet the diagnostic criteria of cervicogenic dizziness. Patients will be randomly allocated to the intervention group and the control group at a ratio of 1:1. Participants in the control group will be treated with Merislon (Betahistine Mesilate Tablets). Participants in the intervention group will be treated with SMT. The primary outcome is the response rate at week 2, which is defined as the proportion of patients who reduce their disability level measured by the Dizziness Handicap Inventory (DHI) score relative to baseline. Key secondary outcomes include DHI scores at weeks 1, 2, and 6 and changes from baseline, time to disappearance of dizziness symptoms, and recurrence rate of dizziness symptoms. Safety will be assessed by adverse events, physical examination and vital signs.</p></div><div><h3>Discussion</h3><p>This trial aims to provide high-quality evidence-based medical data to demonstrate that SMT can reduce dizziness in patients with cervicogenic dizziness effectively and safely.</p></div><div><h3>Trial registration</h3><p>Clinical Trial Registration Center NCT05604937. Registered on Nov 3, 2022.</p></div><div><h3>Protocol version</h3><p>1.0, November 20, 2022.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101349"},"PeriodicalIF":1.4,"publicationDate":"2024-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000966/pdfft?md5=0746cb8292b1b0a677d7c51adf67a5b1&pid=1-s2.0-S2451865424000966-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142049840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Linking clinical trial participants to their U.S. real-world data through tokenization: A practical guide","authors":"Michael J. Eckrote ,&nbsp;Carrie M. Nielson ,&nbsp;Mike Lu ,&nbsp;Tyler Alexander ,&nbsp;Rikisha Shah Gupta ,&nbsp;Kim Wah Low ,&nbsp;Zhiwei Zhang ,&nbsp;Austin Eliazar ,&nbsp;Reyna Klesh ,&nbsp;Andrew Kress ,&nbsp;Matt Bryant ,&nbsp;Alex Asiimwe ,&nbsp;Nicolle M. Gatto ,&nbsp;Nancy A. Dreyer","doi":"10.1016/j.conctc.2024.101354","DOIUrl":"10.1016/j.conctc.2024.101354","url":null,"abstract":"<div><p>In drug development, the use of real-world data (RWD) has augmented our understanding of patients’ health care experiences and the effects of treatments beyond clinical trials. Although electronic health record (EHR) data integration at clinical trial sites is a widely adopted practice, primarily for recruitment and data capture, a challenge to data utility is the fragmentation of health data across different sources.</p><p>Linking RWD sources to each other and to trial data -- while preserving patient privacy through tokenization -- aids in filling evidence gaps with outcome data and facilitates the generalization of effects from controlled trial environments to real-world settings. This paper describes the applications of RWD linkage and how they benefit both clinical development and real-world decision-making. Trial benefits include improving interpretability and generalizability (e.g., by remediating missing data or losses to follow-up), extending follow-up beyond trial closeout, and characterizing the applicability of trial results to under-represented groups.</p><p>The operational aspects of linking trial data to RWD are addressed, emphasizing the importance of using privacy-preserving record linking systems with established metrics of accuracy and precision, managing consent, and providing the necessary training and resources at trial sites to inform participants about providing access to their RWD through data linkage.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101354"},"PeriodicalIF":1.4,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001017/pdfft?md5=b3417adeac61a9fbdd6d2870d5b20542&pid=1-s2.0-S2451865424001017-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142087771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language","authors":"Anne Rivelli ,&nbsp;Osondi Ozoani-Lohrer ,&nbsp;Cheryl Lefaiver ,&nbsp;Maureen Shields ,&nbsp;Andy Marek ,&nbsp;Mercedes Robaina ,&nbsp;Veronica Fitzpatrick","doi":"10.1016/j.conctc.2024.101353","DOIUrl":"10.1016/j.conctc.2024.101353","url":null,"abstract":"<div><h3>Background</h3><p>To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.</p></div><div><h3>Methods</h3><p>This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.</p></div><div><h3>Results</h3><p>Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (&lt;0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p &lt; 0.0001).</p></div><div><h3>Conclusions</h3><p>Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101353"},"PeriodicalIF":1.4,"publicationDate":"2024-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424001005/pdfft?md5=bb106c2f0283635499325954e4a043f0&pid=1-s2.0-S2451865424001005-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142012855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing core outcome set uptake in randomized controlled trials for chronic kidney disease: Cross-sectional analysis","authors":"Alex Hagood ,&nbsp;Logan Patrick Corwin ,&nbsp;Jay S. Modi ,&nbsp;Garrett A. Jones ,&nbsp;Kyle J. Fitzgerald ,&nbsp;Kimberly J. Magana ,&nbsp;Shaelyn A. Ward ,&nbsp;Trevor R. Magee ,&nbsp;Griffin K. Hughes ,&nbsp;Alicia Ito Ford ,&nbsp;Matt Vassar","doi":"10.1016/j.conctc.2024.101347","DOIUrl":"10.1016/j.conctc.2024.101347","url":null,"abstract":"<div><h3>Main problem</h3><p>Chronic kidney disease (CKD) is a progressive condition that affects millions of people worldwide. A standardized core outcome set (COS) was developed for CKD by the International Consortium for Health Outcomes and Measurements in 2019. This study aims to evaluate the frequency of measurement for these outcomes before and after the publication of the COS.</p></div><div><h3>Methods</h3><p>A literature search was done to gather the phase III/IV clinical trials evaluating chronic kidney disease through ClinicalTrials.gov. Data extraction of included studies was completed in a masked, duplicate fashion. The included studies were evaluated for characteristics such as survival, burden of disease, patient-reported health-related quality of life, and treatment modality-specific outcomes.</p></div><div><h3>Results</h3><p>Our results showed that the majority of all COS domains were inadequately measured in CKD clinical trials before and after publication of the COS. Despite the increase in COS measurements following publication, the average percent of COS outcomes measured was less than 40 % per year even after four years.</p></div><div><h3>Conclusion</h3><p>There is a notable deficiency in the complete measurement of COS among all domains both before and after COS publication. We suggest efforts be made to improve the adoption of consistent outcome measures that would benefit the growing population of patients affected by CKD.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101347"},"PeriodicalIF":1.4,"publicationDate":"2024-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000942/pdfft?md5=5bad43fdb5894cc82cad7e0b8b515896&pid=1-s2.0-S2451865424000942-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142040355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recruitment and retention of pediatric participants for pandemic preparedness research: Experience from the PREMISE EV-D68 Pilot Study","authors":"Hai Nguyen-Tran ,&nbsp;Alicen B. Spaulding ,&nbsp;Kevin Messacar ,&nbsp;Matthew R. Vogt ,&nbsp;Perdita Permaul ,&nbsp;Daniel C. Douek ,&nbsp;Abe Mittelman ,&nbsp;Careese Thompson ,&nbsp;Sandy Grubbs ,&nbsp;Christine Magana ,&nbsp;Michelle L. Hernandez","doi":"10.1016/j.conctc.2024.101351","DOIUrl":"10.1016/j.conctc.2024.101351","url":null,"abstract":"<div><p>Recruitment and retention are challenges for prospective pediatric cohort studies, particularly those involving serial venipunctures. We investigated factors underlying enrollment and retention in the Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology (PREMISE) Enterovirus D68 (EV-D68) Pilot Study, a multicenter prospective longitudinal cohort study assessing the utility of immunologic surveillance for pandemic preparedness. This study enrolls children ≤10 years for two blood draws, pre- and post-EV-D68 season, separated by 6–18 months. Overall, 174 children were enrolled in Cohort 1 of the study and 120 (69 %) of children completed the study, with follow-up blood samples obtained from 101 (58 %) of participants. Families were primarily motivated to participate by a desire to help other children, advance science, and better prepare for the next pandemic. Adding research blood draws to clinically indicated blood draws improved enrollment, and multiple study touch points facilitated retention. These findings can be applied to improve recruitment and retention in future pandemic preparedness efforts and longitudinal pediatric cohort studies.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101351"},"PeriodicalIF":1.4,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S245186542400098X/pdfft?md5=f2f2475dd9c315a9b69ebe306ba020d1&pid=1-s2.0-S245186542400098X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141998626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The neurobehavioural effects of cannabidiol in alcohol use disorder: Study protocol for a double-blind, randomised, cross over, placebo-controlled trial","authors":"Tristan P. Hurzeler ,&nbsp;Warren Logge ,&nbsp;Joshua Watt ,&nbsp;Marilena M. DeMayo ,&nbsp;Anastasia Suraev ,&nbsp;Iain S. McGregor ,&nbsp;Paul S. Haber ,&nbsp;Kirsten C. Morley","doi":"10.1016/j.conctc.2024.101341","DOIUrl":"10.1016/j.conctc.2024.101341","url":null,"abstract":"<div><p>Current treatments for alcohol use disorders (AUD) have limited efficacy. Recently, Cannabidiol (CBD) has been examined in a multitude of clinical settings. Preclinical and clinical results suggest that CBD might be particularly well suited for the treatment of AUD and may reduce alcohol cue and stress-induced craving and alcohol seeking. This study aims to investigate this new pharmacotherapy with a particular focus on neurobiological and physiological indicators of craving. <em>Methods</em>: In this double-blind, within-subject, randomised, placebo-controlled, cross-over study, non-treatment seekers will be randomly allocated to three days of four 200 mg CBD gel capsules (800 mg/day) or placebo, with an 18-day washout period. Cognitive, clinical, and neuroimaging assessments will be completed during these three days. The CBD and placebo assessments will be compared. The primary outcomes are i) BOLD signal as a proxy for regional activity during a cue reactivity and a fear response task measured with functional magnetic resonance imaging (fMRI), ii) heart rate variability and skin conductance levels as a proxy for psychophysiological responses to alcohol stimuli. The secondary outcomes are: i) neurometabolite levels (γ-Aminobutyric acid, ethanol, glutathione, and glutamate + glutamine (combined signal)) using magnetic resonance spectroscopy (MRS); ii) functional connectivity using resting state fMRI (rsfMRI); iii) executive functioning task results; iv) clinical outcomes such as craving, anxiety, and sleep. <em>Discussion:</em> This study will improve the understanding of the mechanisms of action of CBD and provide early signals of efficacy regarding the therapeutic potential of CBD in the treatment of alcohol use disorder.</p><p>ClinicalTrials.gov Identifier: NCT05387148.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101341"},"PeriodicalIF":1.4,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000887/pdfft?md5=e866e8877dce231506b2f638eb87f66d&pid=1-s2.0-S2451865424000887-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142012856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continued confusion in mild traumatic brain injury hyperbaric oxygen studies","authors":"Paul G. Harch","doi":"10.1016/j.conctc.2024.101348","DOIUrl":"10.1016/j.conctc.2024.101348","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101348"},"PeriodicalIF":1.4,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000954/pdfft?md5=e715e860eefe575d3ee224b5be69795f&pid=1-s2.0-S2451865424000954-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142002322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A prospective randomized controlled study of multi-intravenous infusion of umbilical cord mesenchymal stem cells in patients with heart failure and reduced ejection fraction (PRIME-HFrEF) trial: Rationale and design","authors":"Xin Gong ,&nbsp;Yuheng Jiao ,&nbsp;Hao Hu ,&nbsp;Rongzhen Zhang ,&nbsp;Wenwen Jia ,&nbsp;Jun Zhao ,&nbsp;Zhongmin Liu ,&nbsp;Yuanfeng Xin ,&nbsp;Wei Han","doi":"10.1016/j.conctc.2024.101350","DOIUrl":"10.1016/j.conctc.2024.101350","url":null,"abstract":"<div><h3>Background and objective</h3><p>The use of mesenchymal stem cells for heart failure treatment has gained increasing interest. However, most studies have relied on a single injection approach, with no research yet confirming the effects of multiple administrations. The present trial aims to investigate the safety and efficacy of multi-intravenous infusion of umbilical cord-mesenchymal stem cells (UC-MSCs) in patients with heart failure and reduced ejection fraction (HFrEF).</p></div><div><h3>Methods</h3><p>The PRIME-HFrEF trial is a single-center, prospective, randomized, <span><span>triple-blinded</span><svg><path></path></svg></span>, placebo-controlled trial of multi-intravenous infusion of UC-MSCs in HFrEF patients. A total of 40 patients meeting the inclusion criteria for HFrEF were enrolled and randomized 1:1 to the MSC group or the placebo group. Patients enrolled will receive intravenous injections of either UC-MSCs or placebo every 6 weeks for three times. Both groups will be followed up for 12 months. The primary safety endpoint is the incidence of serious adverse events. The primary efficacy endpoint is a change in left ventricular ejection fraction (LVEF) measured by left ventricular opacification (LVO) with contrast echocardiography and magnetic resonance imaging (MRI) at 12 months. The secondary endpoints include a composite of the incidence of death and re-hospitalization caused by heart failure at the 12th month, serum NT-proBNP, growth stimulation expressed gene 2 (ST₂), and a change of right ventricular structure and function.</p></div><div><h3>Conclusions</h3><p>The PRIME-HFrEF study is designed to shed new light on multiple UC-MSC administration regimens for heart failure treatment.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101350"},"PeriodicalIF":1.4,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000978/pdfft?md5=686513cfc9869eb7b93103588f639400&pid=1-s2.0-S2451865424000978-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141990688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy","authors":"Ruzha Pancheva ,&nbsp;Stanka A. Fitneva ,&nbsp;Rositsa Chamova ,&nbsp;Dimitar Marinov ,&nbsp;Albena Toneva ,&nbsp;Stanislava Hadzhieva ,&nbsp;Rozalina Braykova ,&nbsp;Nikoleta Yoncheva ,&nbsp;Stefka Tsvetanova ,&nbsp;Silviya Nikolova ,&nbsp;Natalya Usheva ,&nbsp;Koen Huysentruyt ,&nbsp;Karina Dimova ,&nbsp;Yana Bocheva ,&nbsp;Stanislava Pavlova ,&nbsp;Petya Hristanova","doi":"10.1016/j.conctc.2024.101343","DOIUrl":"10.1016/j.conctc.2024.101343","url":null,"abstract":"<div><h3>Introduction</h3><p>Children with Cerebral Palsy (CP) encounter substantial nutritional challenges that impair their health and quality of life. Despite the importance of nutrition in managing CP and the recognition of physiological, behavioral, and social causes of malnutrition, research on the effectiveness of individualized nutritional interventions developed and supported by multidisciplinary teams is scarce.</p></div><div><h3>Aim</h3><p>The study will evaluate the impact of an individualized nutritional intervention developed and supported by a multidisciplinary team on the anthropometric outcomes and overall health of children with CP.</p></div><div><h3>Methods</h3><p>A single-center, randomized controlled trial, conducted at the Medical University of Varna, Bulgaria, will enroll 100 children aged 2–12 years and diagnosed with CP. Participants will be randomly assigned to either an intervention group, receiving comprehensive structured dietary assessment and individualized nutrition plan developed by a multidisciplinary team of experts, or to a standard care group. Outcomes assessed will focus on anthropometric measures of nutritional status, but also include health outcomes, child development and clinical assessments, and quality of life indicators.</p></div><div><h3>Ethics</h3><p>Ethical approval for this study has been obtained from the Medical Ethics Committee at the Medical University of Varna (Protocol No. 134 dated 20.07.2023).</p></div><div><h3>Conclusion</h3><p>This study will assess the benefits of a multidisciplinary, individualized nutritional intervention for children with CP. The findings will have implications for clinical guidelines and interventions aiming to improve their care and quality of life.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"41 ","pages":"Article 101343"},"PeriodicalIF":1.4,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000905/pdfft?md5=44783d01057befebaccffd6efcb4ed66&pid=1-s2.0-S2451865424000905-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141963802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}