Heart Rate Detection during Resuucitation to Reduce Early Neonatal Mortality

描述(由申请人提供)：此申请提供证据，证明首席和高级外国调查人员在全球网络中已有主要成就的既定记录，包括设计、实施和发布单一站点和通用方案研究和临床试验。在接下来的5年周期中，建议进行一项严格设计的多中心整群随机对照临床试验，创新地使用低成本和简单的心率检测器来指导低收入国家初级保健环境中的新生儿复苏，使用标准的美国儿科学会帮助婴儿呼吸方案，以确定其在降低早期(7天)新生儿死亡率方面的有效性。心率检测器将帮助助产士确定心率。5%到10%的新生儿在出生时看起来没有呼吸或哭泣，接生员很难确定心率和其他生命迹象。对于活着出生的婴儿来说，心率增加是有效复苏的最佳指标。心率评估 在现场用通常的临床评估很难进行周皮变化，因此许多婴儿在出生后不久就死亡。即使检测到微弱的心率，新生儿的复苏技能也可以通过心率检测来指导。如果有效，电子心率检测可能是中低技能助产士接生的一个突破。拟议的研究团队已经合作了10多年，并将继续与NICHD和全球网络的其他网站合作，设计、实施、分析和报告创新的随机试验和观察性研究，这些研究可能会降低母婴的死亡率和发病率。调查人员的资历和明确的承诺赞比亚工作人员，以及赞比亚政府、赞比亚大学教学医院(赞比亚)、赞比亚大学和阿拉巴马大学伯明翰分校的全力支持，将确保该网站获得加入该网络的卓越表现。长期目标是通过教育、培训、实施和可持续性方案改善当地卫生保健系统，以降低新生儿死亡率，从而长期降低婴儿死亡率和发病率。

DESCRIPTION (provided by applicant): This application provides evidence that the Principal and Senior Foreign Investigators have an established record of major accomplishments in the Global Network including the design, implementation, and publication of single site and common protocol studies and clinical trials. For the next 5 year cycle, a rigorously-designed multicenter cluster randomized controlled clinical trial of the innovative use of a low cost and simple heart rate detector to guide neonatal resuscitation in primary care settings in low-income countries using the standard American Academy of Pediatrics Helping Babies Breathe protocol is proposed to determine its effectiveness in reducing early (7-day) neonatal mortality. The heart rate detector will assist birth attendants to determine the heart rate. Five to 10 percent of newborn infants appear lifeless at birth without breathing or crying, and determination of the heart rate and other signs of life is difficult for the birth attendants. For infants born alive, a increasing heart rate is the best indicator of an effective resuscitation. Assessment of heart rate changes is difficult to periderm with the usual clinical assessments in the field, and thus many infants die soon after birth. Neonatal resuscitation skills can be guided by heart rate detection even if a feeble heart rate is detected. If effective, electronic heart rate detection may be a breakthrough for deliveries by low- and middle-skilled birth attendants. The proposed team of investigators has collaborated for over 10 years and will continue to work with the NICHD and other sites of the Global Network to design, implement, analyze, and report innovative randomized trials and observational studies that are likely to reduce mortality and morbidities of mothers and infants. The qualifications and unequivocal commitment of the investigators the Zambian staff, as well as the full endorsement of the Government of Zambia, University Teaching Hospital (Zambia), University of Zambia, and the University of Alabama at Birmingham will ensure superior performance if this site is granted participation in the Network. The long-term objective is to improve local health care systems with education, training, implementation, and sustainability of programs to decrease neonatal mortality with the goal of long-term reduction in mortality and morbidity of infants.