Neonatal Resuscitation in Developing Countries

描述（由申请人提供）：该申请提供证据，证明拟议的美国首席研究员在临床试验的设计，实施和发表方面具有建立的领导记录，包括多个多中心和单中心试验。组建的小组由具有高度资格和积极性的调查人员组成，以执行拟议的工作。一项严格设计的多中心临床试验的改进复苏，以减少死亡率，由于围产期窒息提出。围产期窒息已被世界卫生组织（WHO）确定为世界范围内早期死亡的最常见原因，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%。虽然出生后迅速复苏可以防止许多死亡并减少围产期窒息幸存者的残疾，但世卫组织得出的结论是，复苏往往没有开始，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、容易获得且成本有效的干预措施。尽管新生儿复苏计划的原则被推荐用于国际应用，但这一成功的美国计划并未在包括赞比亚在内的许多发展中国家推广，其对新生儿结局的影响尚未在随机对照试验中进行测试。拟议的随机对照试验将确定联合实施新生儿复苏计划/基本新生儿护理计划与卫生保健提供者的基本围产期护理教育（仅基本新生儿护理计划）相比是否能降低围产期窒息死亡率。这项试验将在赞比亚的四个城市进行。研究设计将保证治疗效果评估的有效性、准确性和精密度。如果有效，在全世界范围内对保健工作者进行新生儿复苏培训的进一步努力可大大降低围产期死亡率和发病率。改善新生儿复苏围产期窒息新生儿可能是最具成本效益的围产期护理干预措施之一。拟议的研究小组将与NICHD和全球妇女儿童健康研究网络的其他中心合作，设计、优先考虑、计划、实施、分析、解释和报告有可能改善孕产妇和儿童生存率和其他重要结果的创新性随机试验和观察性研究。如果这项申请得到资助，美国首席调查员、高级外国调查员和调查团队的资格和明确承诺，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面认可，将确保卓越的表现。

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.