Neonatal Resuscitation in Developing Countries

描述（由申请人提供）：本申请提供的证据表明，拟议的美国主要研究者在临床试验（包括多个多中心和单中心试验）的设计、实施和出版方面具有既定的领导记录。组建的小组由高素质的调查员组成，他们有动力开展拟议的工作。一个严格设计的多中心临床试验，改善复苏，以减少死亡率由于围产期窒息的建议。围产期窒息已被世界卫生组织（WHO）确定为全球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、容易获得且具有成本效益的干预措施。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尚未在包括赞比亚在内的许多发展中国家传播，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与仅对医疗保健提供者进行基本围产期保健教育（仅新生儿基本保健计划）相比，实施新生儿复苏计划/新生儿基本保健计划是否会降低围产期窒息导致的死亡率。该试验将在赞比亚的四个城市进行。研究设计将确保治疗效应估计的有效性、准确性和精密度。如果有效的话，进一步努力培训全世界的保健工作者进行新生儿复苏，可能会大大降低围产期死亡率和发病率。改善新生儿复苏的新生儿围产期窒息可能是最具成本效益的干预措施之一，在围产期保健。拟议的研究人员团队将与NICHD和全球妇女和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，解释和报告创新的随机试验和观察性研究，这些试验和观察性研究可能会改善孕产妇和儿童的生存率和其他重要结果。美国首席研究员、高级外国研究员和研究团队的资格和明确承诺，以及赞比亚政府、赞比亚大学和亚拉巴马大学伯明翰分校的充分认可，将确保本申请获得资助后的上级表现。

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.