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: 10507301
• 负责人: Bridget Mary Hron
• 金额: $ 19.42万
• 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/10507301
• 关键词: Address; Admission activity; Adopted; Adult; Advisory Committees; Affect; Area; Aspiration Pneumonia; Berry; Biometry; Bolus Infusion; Boston; Child; Childhood; Chronic Disease; 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; 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; Master of Science; Measures; Meat; Mediator of activation protein; 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; Techniques; Testing; Thick; Time; Training; Training Activity; Tube; Universities; 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; fruits and vegetables; 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.

项目概要 具有医疗复杂性的脆弱儿童群体（患有先天性或后天性多系统疾病的儿童） 疾病、神经功能障碍和/或对医疗技术的依赖）占总数的三分之一 儿科医疗支出的系统调查营养对慢性疾病负担的影响。 在这一人群中尚未完成但迫切需要，因为它具有优化临床结果的巨大潜力 Bridget Hron 博士是一名儿科医师。 胃肠病学家和营养专家，接受过新陈代谢和营养调节方面的高级培训 她非常适合解决这一未满足的关键需求，她的职业目标是指导临床。 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 改变最弱势儿科人群的临床护理。 在 Hron 博士最近的工作中，她证明了混合饮食，即高质量的餐桌食品，例如 因为通过胃造口管给予水果、蔬菜、肉类和豆类对健康有益 在此职业发展过程中，因肺部原因入院的人数减少了 53%。 Hron 博士将研究不同粘度的混合饲料对胃肠道症状和 食管和胃功能的创新性总体随机、对照 N-of-1 研究设计。 该提案中概述的允许每个参与者确定最大功效的饮食，但也允许 用于估计干预措施的人口效应。 该职业发展奖中提出的卓越指导和原创科学培训至关重要 Hron 博士的主要导师 Rachel Rosen 博士是呼吸消化医学专家， 共同导师 Christopher Schmid 博士是一位生物统计学专家，专注于 N-of-1 试验——两人都拥有 她拥有出色的临床研究背景以及对指导的坚定承诺。 奖学金咨询委员会由 Wayne Lencer 博士、Christopher Duggan 博士、Jay Berry 博士和 Sharon 博士组成 多诺万提供内容领域的专业知识，她的正式培训将包括理学硕士学位：专注。 伊利诺伊大学香槟分校食品科学专业，统计分析高级课程 哈佛大学陈曾熙公共卫生学院 (HSPH)，关于食管和胃介质的个人指导 罗森博士的活力，以及通过 HSPH 和哈佛 Catalyst 培训的专业发展课程。 和研究活动将在波士顿儿童医院无与伦比的学术环境中进行 医院和哈佛医学院坚定致力于赫伦博士成功过渡到 独立的研究生涯。