Heart Rate Detection during Resuucitation to Reduce Early Neonatal Mortality

描述（由申请人提供）：本申请提供的证据表明，主要研究者和高级外国研究者在全球网络中具有既定的主要成就记录，包括设计、实施和发表单中心和通用方案研究和临床试验。在接下来的5年周期中，提出了一项严格设计的多中心群集随机对照临床试验，旨在确定其在降低早期（7天）新生儿死亡率方面的有效性，该试验采用标准的美国儿科学会帮助婴儿呼吸方案，在低收入国家的初级保健环境中创新使用低成本和简单的心率检测器来指导新生儿复苏。心率检测器将协助助产士确定心率。5%到10%的新生儿在出生时没有呼吸或哭泣，并且很难确定心率和其他生命体征。对于活产婴儿，心率的增加是有效复苏的最佳指标。评估心率 这些变化很难用该领域的通常临床评估来确定，因此许多婴儿出生后不久就死亡。即使检测到微弱的心率，也可以通过心率检测来指导新生儿复苏技能。如果有效，电子心率检测可能是中低技能助产士分娩的一个突破。拟议的研究人员团队已经合作了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，分析和报告可能降低母婴死亡率和发病率的创新随机试验和观察性研究。调查人员、赞比亚工作人员的资格和明确承诺，以及赞比亚政府、大学教学医院（赞比亚）、赞比亚大学和伯明翰亚拉巴马大学的充分支持，将确保该研究中心在获准加入网络后取得上级业绩。长期目标是通过教育、培训、实施和可持续性方案改善地方保健系统，以降低新生儿死亡率，实现长期降低婴儿死亡率和发病率的目标。

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.