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

OMWaNA 研究：在非洲临床不稳定的低出生体重新生儿中实施袋鼠式母亲护理

• 批准号: 10161805
• 负责人: Melissa Morgan Medvedev
• 金额: $ 18.95万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10161805
• 关键词: Address; Adherence; Affect; Africa; Area; Award; Biometry; Birth; Breast Feeding; California; Care given by nurses; Caring; Cessation of life; Child Health; Childhood; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Community Health Aides; Conduct Clinical Trials; Cost Effectiveness Analysis; Cost Measures; Cost Savings; Counseling; Data; Data Analyses; Data Set; Department chair; Development; Development Plans; Doctor of Philosophy; Economic Factors; Educational workshop; Elderly; Elements; Environment; Epidemiology; Ethiopia; Expenditure; Faculty; Family; Fatigue; Foundations; Gender Role; Goals; Guidelines; Guilt; Health; Health Planning; Health Policy; Health system; Home; Hospital Referrals; Hospitals; Hour; Household; Hygiene; Incubators; India; Infant Care; Intensive Care; Intervention; Interview; K-Series Research Career Programs; Kangaroo-Mother Care; Lead; Length of Stay; Life; London; Long-Term Care; Low Birth Weight Infant; Maternal Health; Maternal and Child Health; Melissa; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Meta-Analysis; Methods; Modeling; Mothers; Neonatal; Neonatal Mortality; Neonatology; Newborn Infant; Outcome; Pain; Participant; Pediatrics; Play; Policy Developments; Positioning Attribute; Premature Birth; Prevention; Preventive Medicine; Procedures; Productivity; Protocols documentation; Provider; Public Health; Public Health Schools; Publishing; Randomized Controlled Trials; Reading; Recommendation; Reporting; Reproductive Health; Research; Research Design; Research Personnel; Research Project Grants; Research Training; Resources; Role; Sampling; San Francisco; Schools; Sepsis; Skin; Statistical Methods; Supervision; Supportive care; Surveys; Time; Training; Tropical Medicine; Uganda; Universities; Visit; Vulnerable Populations; Work; World Health Organization; Writing; adolescent health; arm; care providers; career; career development; college; cost effectiveness; cost estimate; cost-effectiveness evaluation; cost-effectiveness ratio; design; economic evaluation; evidence base; experience; follow-up; global health; health economics; health organization; implementation cost; implementation science; improved; incremental cost-effectiveness; innovation; low and middle-income countries; mid-career faculty; mortality; natural hypothermia; neonatal care; neonatal death; neonatal health; neonate; peer; pilot trial; prevent; productivity loss; professor; public health intervention; recruit; research and development; routine care; screening; skills; social; social stigma; success; symposium; systems research; time use; treatment arm; trial comparing; trial design; uptake

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.

项目概要/摘要： 职业目标：这是一个重新提交的K23职业发展奖梅丽莎摩根，医学博士，硕士， 他是加州大学旧金山弗朗西斯科（UCSF）的儿科助理教授。她以前 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 目的是建立在她的初步工作评估使用袋鼠母亲护理（KMC）在临床不稳定 乌干达的新生儿。摩根博士致力于学术研究的职业生涯，专注于进行 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。的技能和 她将从K23奖项中获得的经验将使她为竞争R 01提案做好准备， 比较KMC与保温箱护理对临床早期死亡率的影响的随机对照试验（RCT） ≤2000 g的不稳定新生儿，同时进行成本效益和经济学评价。 摩根有加州大学旧金山分校的充分和热情的支持，这有一个传统， 卓越的临床研究和全球健康，许多研究人员追求孕产妇的创新理念， 和儿童健康的影响。UCSF为初级教师提供大量支持。 研究职业发展计划的关键要素：摩根博士是一位具有强大 在低资源环境下进行临床研究的背景。她在研究设计、定量 定性数据分析，科学写作和管理研究团队。虽然这些经验 提供了一个坚实的基础，有三个领域，她需要额外的培训，以实现 她的职业目标，包括1）KMC和实施科学的高级培训，2）成本技能， 有效性和经济分析，以及3）影响临床试验和 进行试点试验的经验。摩根博士组建了一支优秀的培训和指导团队 由她的主要导师，乔治卢瑟福，医学博士，FAAP，流行病学教授，预防医学， 流行病学和生物统计学系副主任兼预防中心主任 他在儿科实施科学和流行病学方面拥有专业知识 在低资源环境中。她的共同导师是Joy Lawn，MBBS，MPH，PhD，教授和主任。 伦敦卫生学院的孕产妇、青少年、生殖和儿童健康（MARCH）中心 和热带医学（LSHTM），他们开发了证据基础，以解决全球新生儿疾病负担问题。 死亡率，并在评估KMC作为一种公共卫生干预措施方面发挥了主导作用，Peter Waiswa， MBChB，公共卫生硕士，博士，卫生政策和规划副教授，孕产妇和 乌干达马凯雷雷大学新生儿卓越中心，他在雇用 研究干预措施，以解决新生儿死亡率问题。摩根博士的团队包括两名合作者： Kahn，MD MPH，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健康干预成本效益分析专家， Shiboski博士，加州大学旧金山分校生物统计学教授，在开发统计方法方面拥有丰富的经验 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，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，是应用专家 的因果推理方法，以观察临床数据集。Cally Tann，MBChB，MSc，PhD，新生儿学家 伦敦大学学院伦敦医院儿童健康发展临床副教授， LSHTM拥有生殖医学和新生儿试验方面的专业知识，包括在乌干达。摩根博士正在攻读博士学位 在LSHTM教授的监督下草坪，她的培训计划包括在加州大学旧金山分校，LSHTM， UCB;定向阅读和教程;参观KMC卓越中心;以及研讨会和会议。 研究项目描述：每年有270万新生儿死亡，其中大多数是 其中48小时内发生在低资源环境中的不稳定新生儿中。KMC与 体重≤ 2000 g的稳定新生儿死亡率降低。本研究的总体目标是批判性地探索 KMC在乌干达不稳定新生儿中的作用。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。目的1将探讨影响KMC摄取和持续时间的因素， 利用调查结果制定策略，以改善设施中的KMC实践。目标2将制定和实施 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，以估计KMC对死亡率的影响相对于孵化器护理，并评估 全面RCT的可行性。研究结果将为RCT的R 01提案的制定提供信息，以确定 在≤ 2000 g的不稳定新生儿中，与保温箱护理相比，KMC对7天内死亡率的影响。 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 她的研究和职业发展计划此外，她已经有了生产力的跟踪记录， 她的导师们成功竞争R 01并实现独立将是 许多富有成效和丰富的临床研究经验。UCSF提供的机会，并通过 她的指导团队将使摩根博士成为领先的新生儿临床试验和卫生系统 研究人员，实施和评估干预措施，以改善低资源环境中的新生儿健康。