The OMWaNA Study: Operationalizing kangaroo Mother care among clinically unstable low birth Weight Neonates in Africa

项目摘要/摘要： 职业目标：这是对梅丽莎·摩根的K23职业发展奖的重新提交， 世卫组织是加州大学旧金山分校(UCSF)儿科学助理教授。她的前妻 研究的重点是在东非和印度实施新生儿干预措施。在这个奖项中，她 旨在建立在她的初步工作的基础上，评估袋鼠母亲护理(KMC)在临床不稳定中的使用 乌干达的新生儿。摩根博士致力于学术新生儿学的事业，专注于 临床试验和卫生系统研究，以改善低资源环境下的新生儿健康。技能和 她将从这个K23奖项中获得的经验将为她竞争R01提案做好准备，以进行 KMC与孵化器护理对临床早期死亡率影响的随机对照试验(RCT) 不稳定新生儿≤2,000克，附带成本-效果和经济评价。 环境：摩根博士得到加州大学旧金山分校的全力和热情支持，该校有 在临床研究和全球健康方面的卓越表现，许多研究人员在孕产妇领域寻求创新想法 以及低收入和中等收入国家的儿童健康。加州大学旧金山分校为初级教员提供大量支持。 研究职业发展计划的关键要素：摩根博士是一位新生儿专家，有很强的 低资源环境下的临床研究背景。她有研究设计、定量研究的经验 以及定性数据分析、科学写作和研究团队管理。虽然这些经历有 提供了坚实的基础，她需要在三个领域进行额外的培训才能实现 她的职业目标包括1)KMC和实施科学方面的高级培训，2)成本方面的技能- 有效性和经济分析，以及3)关于影响临床试验和 有进行试点试验的经验。摩根博士组建了一支出色的培训和指导团队 在她的主要导师，医学博士，FAAP，流行病学，预防医学教授乔治·卢瑟福的带领下， 和儿科，流行病学和生物统计学系副主任兼预防主任 和加州大学旧金山分校的公共卫生小组，他们在儿科实施科学和流行病学方面拥有专长 在资源不足的环境中。她的共同导师是喜悦·劳恩，MBBS，公共卫生硕士，博士，教授兼 伦敦卫生学院孕产妇、青少年、生殖和儿童健康中心(3月) 和热带医学(LSHTM)，他们开发了解决全球新生儿负担的证据基础 死亡率，并在评估KMC作为公共卫生干预措施方面发挥了主导作用，Peter Waiswa， 医学硕士，公共卫生硕士，博士，卫生政策和规划副教授，妇产科主任 乌干达Makerere大学新生儿卓越中心，他拥有丰富的招聘经验 应对新生儿死亡率的研究干预措施。摩根博士的团队包括两名合作者：詹姆斯 卡恩，医学硕士，卫生政策和流行病学教授，全球卫生经济学主任 加州大学旧金山分校的一位卫生干预成本效益分析专家和斯蒂芬 ShiBoski博士，加州大学旧金山分校生物统计学教授，具有开发统计方法的丰富经验 在非洲进行试验。她还确定了两名顾问：玛雅·彼得森，医学博士，副教授 加州大学伯克利分校(UCB)公共卫生学院的生物统计学和流行病学是应用方面的专家 对观察性临床数据集的因果推断方法。Cally Tann，MBCHB，理学硕士，博士，新生儿科医生 伦敦大学学院医院儿童健康发展临床副教授 LSHTM在新生儿学和新生儿试验方面拥有专业知识，包括在乌干达。摩根博士正在攻读博士学位 在LSHTM，在Lawn教授的指导下，她的培训计划包括在加州大学旧金山分校、LSHTM和 UCB；定向阅读和教程；参观KMC英才中心；以及讲习班和会议。 研究项目简介：每年有270万新生儿死亡，其中大多数 其中，在资源匮乏的环境中，不稳定的新生儿在48小时内发生。KMC与 降低稳定新生儿死亡率≤2000G。这项研究的总体目标是批判性地探索使用 在乌干达不稳定的新生儿中发现了KMC。她的核心假设是，与孵化器相比，KMC将 降低死亡率并节省成本。目标1将探索影响KMC摄取和持续时间的因素，以及 利用调查结果制定策略，以改进设施中的KMC实践。目标2将开发和实施 模型比较KMC和孵化器护理的增量成本和成本效益。在《目标3》中，她将 进行试点试验，以评估KMC相对于孵化器护理对死亡率的影响，并评估 全面开展随机对照试验的可行性。调查结果将为R01提案的制定提供信息，以供RCT确定 在不稳定新生儿≤2000G中，KMC与孵化器护理对7天内死亡率的影响比较。 摩根博士组建了一支经验丰富、资源充足的导师团队，致力于 她提出的研究和职业发展。此外，她已经有了生产力的记录， 她的导师。成功竞争R01并实现独立将是 许多富有成效和丰富的临床研究经验。在加州大学旧金山分校和通过 她的指导团队将使摩根博士做好准备，成为领先的新生儿临床试验者和卫生系统 研究人员，实施和评估在低资源环境下改善新生儿健康的干预措施。

Project Summary/Abstract: Career Goals: This is a resubmission for a K23 Career Development Award for Melissa Morgan, MD, MSc, who is Assistant Professor of Pediatrics at the University of California, San Francisco (UCSF). Her previous research has centered on implementation of neonatal interventions in East Africa and India. In this award, she aims to build on her preliminary work evaluating the use of kangaroo mother care (KMC) in clinically unstable neonates in Uganda. Dr. Morgan is committed to a career in academic neonatology, focused on conducting clinical trials and health systems research to improve newborn health in low-resource settings. The skills and experience she will gain from this K23 award will prepare her to compete for an R01 proposal to conduct a randomized controlled trial (RCT) comparing the effect of KMC to incubator care on early mortality in clinically unstable neonates ≤2000 grams, with an accompanying cost-effectiveness and economic evaluation. Environment: Dr. Morgan has the full and enthusiastic support of UCSF, which has a tradition of excellence in clinical research and global health with many investigators pursuing innovative ideas in maternal and child health in low and middle-income countries. UCSF provides substantial support for junior faculty. Key Elements of Research Career Development Plan: Dr. Morgan is a neonatologist with a strong background in clinical research in low-resource settings. She has experience in study design, quantitative and qualitative data analysis, scientific writing, and managing research teams. While these experiences have provided a robust foundation, there are three areas where she requires additional training in order to achieve her career goals, including 1) advanced training in KMC and implementation science, 2) skills in cost- effectiveness and economic analysis, and 3) advanced training in statistical issues affecting clinical trials and experience conducting a pilot trial. Dr. Morgan has assembled an outstanding training and mentoring team led by her primary mentor, George Rutherford, MD, FAAP, Professor of Epidemiology, Preventive Medicine, and Pediatrics, Vice Chair of the Department of Epidemiology and Biostatistics and Director of the Prevention and Public Health Group at UCSF, who has expertise in pediatric implementation science and epidemiology in low-resource settings. Her co-mentors are Joy Lawn, MBBS, MPH, PhD, Professor and Director of the Maternal, Adolescent, Reproductive, and Child Health (MARCH) Center at the London School of Hygiene and Tropical Medicine (LSHTM), who developed the evidence base to address the global burden of neonatal mortality and played a leading role in evaluating KMC as a public health intervention, and Peter Waiswa, MBChB, MPH, PhD, Associate Professor of Health Policy and Planning and Director of the Maternal and Newborn Center of Excellence at Makerere University in Uganda, who has extensive experience employing research interventions to address neonatal mortality. Dr. Morgan’s team includes two collaborators: James Kahn, MD MPH, Professor of Health Policy and Epidemiology and Director of the Global Health Economics Consortium at UCSF, who is an expert in cost-effectiveness analysis for health interventions, and Stephen Shiboski, PhD, Professor of Biostatistics at UCSF, who has broad experience developing statistical methods for trials in Africa. She has also identified two consultants: Maya Peterson, MD, PhD, Associate Professor of Biostatistics and Epidemiology at the UC Berkeley (UCB) School of Public Health, is an expert on application of causal inference methods to observational clinical datasets. Cally Tann, MBChB, MSc, PhD, Neonatologist at University College London Hospital and Clinical Associate Professor of Child Health Development at LSHTM, has expertise in neonatology and neonatal trials, including in Uganda. Dr. Morgan is pursuing a PhD at LSHTM under the supervision of Prof. Lawn, and her training plan includes courses at UCSF, LSHTM, and UCB; directed readings and tutorials; a visit to a KMC Center of Excellence; and workshops and conferences. Description of the Research Project: There are 2.7 million neonatal deaths each year, and the majority of these occur among unstable neonates within 48 hours in low-resource settings. KMC is associated with decreased mortality among stable neonates ≤2000g. The overall aim of this study is to critically explore the use of KMC in unstable neonates in Uganda. Her central hypothesis is that, compared to incubators, KMC will reduce mortality and lead to cost savings. Aim 1 will explore factors that affect KMC uptake and duration, and use findings to develop strategies to improve KMC practice in facilities. Aim 2 will develop and implement a model to compare the incremental cost and cost-effectiveness of KMC and incubator care. In Aim 3, she will conduct a pilot trial to estimate the effect of KMC on mortality relative to incubator care and evaluate the feasibility of a full-scale RCT. Findings will inform the development of an R01 proposal for an RCT to determine the effect of KMC on mortality within 7 days compared to incubator care among unstable neonates ≤2000g. Dr. Morgan has assembled a highly experienced and well-resourced mentorship team that is committed to her proposed research and career development. Moreover, she already has a track record of productivity with her mentors. To successfully compete for an R01 and achieve independence would be the culmination of many productive and enriching clinical research experiences. The opportunities available at UCSF and through her mentoring team will prepare Dr. Morgan to become a leading neonatal clinical trialist and health systems researcher, implementing and evaluating interventions to improve newborn health in low-resource settings.