Neonatal Resuscitation in Developing Countries

描述(由申请人提供)：本申请提供证据，证明拟议的美国首席调查员在临床试验的设计、实施和发表方面拥有既定的领导记录，包括多个多中心和单中心试验。组建的团队由高素质和有动力执行拟议工作的调查人员组成。一项严格设计的多中心临床试验改进复苏以降低围产期窒息死亡率被提出。围产期窒息已被世界卫生组织(WHO)确定为全球最常见的早期死亡原因，约占新生儿死亡率的20%。在赞比亚，围产期窒息约占新生儿死亡率的40%。虽然出生后及时复苏可以防止许多幸存者因围产期窒息而死亡并减少残疾，但世卫组织得出的结论是，复苏往往没有启动，或者使用的方法不充分或错误。新生儿复苏是一种简单、廉价、容易获得和成本效益高的干预措施。尽管新生儿复苏计划的原则被推荐在国际上应用，但这一成功的美国计划尚未在包括赞比亚在内的许多发展中国家得到传播，其对新生儿结局的影响也没有在随机对照试验中进行测试。拟议的随机对照试验将确定实施新生儿复苏计划/基本新生儿护理计划与仅实施保健提供者的基本围产期护理教育(仅限基本新生儿护理计划)是否能降低围产期窒息造成的死亡率。这项试验将在赞比亚的四个城市进行。研究设计将确保治疗效果估计的有效性、准确性和精确度。如果有效，对世界各地的医护人员进行新生儿复苏培训的进一步努力可能会显著降低围产儿死亡率和发病率。对围产期窒息的新生儿进行改进的新生儿复苏可能是围产期护理中最具成本效益的干预措施之一。拟议的调查团队将与NICHD和全球妇女儿童健康研究网络的其他中心合作，设计、确定优先顺序、计划、实施、分析、解释和报告创新的随机试验和观察性研究，这些研究可能会改善母婴存活率和其他重要结果。美国首席调查员、高级外国调查员和调查团队的资历和明确承诺，以及赞比亚政府、赞比亚大学和阿拉巴马大学伯明翰分校的全力支持，将确保本申请获得资助后的卓越表现。

DESCRIPTION (provided by applicant): This application provides evidence that the proposed U.S. Principal Investigator has an established leadership record in the design, implementation, and publication of clinical trials, including several multicenter and single center trials. The assembled team consists of investigators highly qualified and motivated to perform the proposed work. A rigorously designed multicenter clinical trial of improved resuscitation to reduce mortality due to perinatal asphyxia is proposed. Perinatal asphyxia has been identified by the World Health Organization (WHO) as the most frequent cause of early deaths worldwide, accounting for about 20% of neonatal mortality. In Zambia, perinatal asphyxia accounts for about 40% of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from perinatal asphyxia, WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. Neonatal resuscitation is a simple, inexpensive, readily available, and cost effective intervention. Even though the principles of the Neonatal Resuscitation Program are recommended for international application, this successful U.S. program has had no dissemination in many developing countries including Zambia, and its effects on neonatal outcome have not been tested in a randomized controlled trial. The proposed randomized controlled trial will determine if implementation of the combined Neonatal Resuscitation Program/Essential Newborn Care Program compared to only basic perinatal care education of health care providers (Essential Newborn Care Program only) results in reduced mortality due to perinatal asphyxia. The trial will be performed in four cities in Zambia. The study design will assure validity, accuracy, and precision of the estimate of the treatment effects. If effective, further efforts to train healthcare workers worldwide in neonatal resuscitation could result in important reductions in perinatal mortality and morbidity. Improved neonatal resuscitation for newly born infants with perinatal asphyxia may be one of the most cost effective interventions in perinatal care. The proposed team of investigators will work with the NICHD and other centers of the Global Network for Women and Children's Health Research to design, prioritize, plan, implement, analyze, interpret, and report innovative randomized trials and observational studies that are likely to improve maternal and childhood survival and other important outcomes. The qualifications and unequivocal commitment of the U.S. Principal Investigator, the Senior Foreign Investigator, and the team of investigators, as well as the full endorsement of the Government of Zambia, the University of Zambia, and the University of Alabama at Birmingham will ensure superior performance if this application is funded.