A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-08-07 DOI:10.1016/j.conctc.2024.101343

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

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Abstract

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.

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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

导言脑瘫（CP）儿童面临着巨大的营养挑战，这损害了他们的健康和生活质量。该研究将评估由多学科团队开发和支持的个性化营养干预对 CP 儿童人体测量结果和整体健康的影响。方法在保加利亚瓦尔纳医科大学进行的单中心随机对照试验将招募 100 名年龄在 2-12 岁、被诊断为 CP 的儿童。参与者将被随机分配到干预组（接受由多学科专家团队制定的全面结构化饮食评估和个性化营养计划）或标准护理组。评估结果将侧重于营养状况的人体测量指标，但也包括健康结果、儿童发育和临床评估以及生活质量指标。伦理本研究已获得瓦尔纳医科大学医学伦理委员会的伦理批准（2023 年 7 月 20 日第 134 号协议）。研究结果将对旨在改善其护理和生活质量的临床指南和干预措施产生影响。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

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.