A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology

一项新颖的 N-of-1 随机对照临床试验，用于评估混合管饲对食管胃生理学的影响

• 批准号: 10682492
• 负责人: Bridget Mary Hron
• 金额: $ 19.28万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10682492
• 关键词: Address; Admission activity; Adopted; Adult; Advisory Committees; Affect; Aspiration Pneumonia; Berry; Biometry; Bolus Infusion; Boston; Child; Child health care; Childhood; Chronic Disease; Classification; Clinical; Clinical Management; Clinical Research; Clinical Trials; Coughing; Coupled; Cross-Over Studies; Data; Deglutition; Dependence; Development; Diet; Dietary Intervention; Disease; Enteral; Enteral Feeding; Environment; Esophagus; Event; Expenditure; Fabaceae; Feeds; Food; Fruit; Functional disorder; Fundus; Future; Gastric Emptying; Gastroenterologist; Gastroesophageal reflux disease; Gastroparesis; Gastrostomy; Goals; Health; Health Care Costs; Health Expenditures; Heterogeneity; Hospitalization; Illinois; Impairment; Individual; Infant; Inferior esophageal sphincter structure; Inflammation; Ingestion; Instruction; Investigation; K-Series Research Career Programs; Literature; Location; Lung; Macronutrients Nutrition; Master of Science; Measures; Meat; Mediator; Medical; Medical Technology; Medicine; Mentors; Mentorship; Metabolism; Methodology; Methods; Micronutrients; Nausea and Vomiting; Neurologic; Nutritional; Observational Study; Outcome; Parents; Participant; Patients; Pediatric Hospitals; Physicians; Physiological; Physiology; Population; Public Health Schools; Quality of life; Questionnaires; Radionuclide Imaging; Randomized; Randomized Controlled Clinical Trials; Randomized, Controlled Trials; Reflux; Regulation; Research; Research Activity; Research Design; Research Personnel; Scholarship; Secondary to; Specialist; Statistical Data Interpretation; Stomach; Symptoms; System; Techniques; Testing; Time; Training; Training Activity; Tube; Universities; Vegetables; Viscosity; Vulnerable Populations; Work; burden of illness; career; catalyst; cell motility; chemical property; clinical care; course development; design; diaries; evidence base; experience; feeding; food science; gastrointestinal; gastrointestinal symptom; health care service utilization; improved; indexing; innovation; intervention effect; medical schools; novel; novel marker; nutrition; physical property; preservation; primary outcome; programs; prospective; pulmonary symptom; reduce symptoms; response; secondary outcome; statistical learning; stroke victims; symptomatic improvement; symptomatology; trial comparing; trial design

PROJECT SUMMARY The fragile population of children with medical complexity (children with congenital or acquired multisystem disease, neurologic impairment and/or dependence on medical technology) accounts for up to one third of all pediatric medical expenditure. Systematic investigation of the contribution of nutrition to chronic disease burden in this population has not been done and is urgently needed, as it has vast potential to optimize clinical outcomes such as feeding intolerance, improve quality of life and reduce healthcare cost. Dr. Bridget Hron is a pediatric gastroenterologist and nutrition specialist with advanced training in the nutritional regulation of metabolism and inflammation who is perfectly suited to address this critical unmet need. Her career goal is to direct a clinical research program focused on discovering evidenced-based, state of the art nutritional interventions that transform the clinical care of the most vulnerable pediatric population. In Dr. Hron's recent work, she has shown that blenderized diets, which are pureed high quality table foods such as fruits, vegetables, meat and legumes administered via gastrostomy tube have a beneficial effect on health care utilization, reducing admissions for pulmonary reasons by 53%. Over the course of this career development award, Dr. Hron will study the effect of blenderized feeds varying in viscosity on gastrointestinal symptoms and on esophageal and gastric function. The innovative aggregate randomized, controlled N-of-1 study design outlined in this proposal allows each individual participant to determine diet of maximal efficacy, but also allows for estimation of population effect of the interventions. The exceptional mentorship and original scientific training proposed in this career development award are critical for Dr. Hron's academic development. Dr. Rachel Rosen, primary mentor, is an expert in aerodigestive medicine, and Dr. Christopher Schmid, co-mentor, is an expert in biostatistics with a focus on N-of-1 trials – both have outstanding backgrounds in clinical research with deep commitment to mentorship. She will be supported by her Scholarship Advisory Committee consisting of Drs. Wayne Lencer, Christopher Duggan, Jay Berry and Sharon Donovan, who lend content-area expertise. Her formal training will include a Master of Science: Concentration in Food Science at University of Illinois Urbana-Champaign, advanced courses in statistical analysis at the Harvard T.H. Chan School of Public Health (HSPH), personal instruction on mediators of esophageal and gastric motility by Dr. Rosen, and professional development courses through HSPH and Harvard Catalyst. Her training and research activities will be conducted in the unparalleled academic environments of Boston Children's Hospital and Harvard Medical School, which are firmly committed to Dr. Hron's successful transition to an independent research career.

项目摘要 具有医学复杂性的脆弱儿童人群（先天性或获得性多系统发育障碍的儿童） 疾病、神经功能障碍和/或对医疗技术的依赖）占所有残疾人的三分之一。 儿科医疗支出。营养对慢性病负担贡献的系统调查 在这一人群中尚未完成，迫切需要，因为它具有优化临床结果的巨大潜力 如喂养不耐受、改善生活质量和降低医疗费用。布丽奇特·赫伦医生是一名儿科医生 胃肠病学家和营养专家，在代谢的营养调节方面受过高级培训， 炎症谁是完全适合解决这一关键的未满足的需求。她的职业目标是指导一个临床 研究计划的重点是发现基于证据的最先进的营养干预措施， 改变最脆弱的儿科人群的临床护理。 在Hron博士最近的工作中，她已经表明，混合饮食，也就是高质量的餐桌食物， 因为经由胃造口管进食的水果、蔬菜、肉类及豆类对健康有益 护理利用率，减少了53%的肺部原因入院。在这个职业发展的过程中， Hron博士将研究不同粘度的混合饲料对胃肠道症状的影响， 对食管和胃功能的影响创新的总体随机化、对照N-of-1研究设计 该建议中概述的内容允许每个参与者确定最大功效的饮食，但也允许 估计干预措施的人口效应。 在这个职业发展奖中提出的特殊指导和原创科学培训至关重要 Hron博士的学术发展瑞秋罗森医生，主要导师，是呼吸消化医学专家， 克里斯托弗·施密德博士，共同导师，是生物统计学专家，专注于N-of-1试验-两人都有 具有临床研究的优秀背景，并致力于指导。她将得到她的支持 奖学金咨询委员会由博士组成。韦恩Lencer，克里斯托弗·达根，杰伊·贝瑞和沙龙 多诺万，谁借给内容领域的专业知识。她的正式培训将包括科学硕士：专注 伊利诺伊大学厄巴纳-香槟分校食品科学专业，统计分析高级课程， 哈佛T. H. Chan公共卫生学院（HSPH），食管和胃介质的个人指导 由罗森博士提供的动力学课程，以及通过HSPH和哈佛催化剂提供的专业发展课程。她的训练 研究活动将在波士顿儿童学院无与伦比的学术环境中进行。 医院和哈佛医学院，这是坚定地致力于博士的成功过渡到一个 独立的研究生涯。