{"title":"为脑瘫儿童引入多学科个性化营养干预的随机对照试验方案","authors":"Ruzha Pancheva , Stanka A. Fitneva , Rositsa Chamova , Dimitar Marinov , Albena Toneva , Stanislava Hadzhieva , Rozalina Braykova , Nikoleta Yoncheva , Stefka Tsvetanova , Silviya Nikolova , Natalya Usheva , Koen Huysentruyt , Karina Dimova , Yana Bocheva , Stanislava Pavlova , Petya Hristanova","doi":"10.1016/j.conctc.2024.101343","DOIUrl":null,"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":null,"pages":null},"PeriodicalIF":1.4000,"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":"0","resultStr":"{\"title\":\"A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy\",\"authors\":\"Ruzha Pancheva , Stanka A. Fitneva , Rositsa Chamova , Dimitar Marinov , Albena Toneva , Stanislava Hadzhieva , Rozalina Braykova , Nikoleta Yoncheva , Stefka Tsvetanova , Silviya Nikolova , Natalya Usheva , Koen Huysentruyt , Karina Dimova , Yana Bocheva , Stanislava Pavlova , Petya Hristanova\",\"doi\":\"10.1016/j.conctc.2024.101343\",\"DOIUrl\":null,\"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\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"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\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Contemporary Clinical Trials Communications\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2451865424000905\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865424000905","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy
Introduction
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.
Aim
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.
Methods
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.
Ethics
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).
Conclusion
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.
期刊介绍：
Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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