Sepsis and Critical Illness in Babies > 34 Weeks Gestation

妊娠 34 周以上婴儿的败血症和危重疾病

• 批准号: 7090169
• 负责人: GABRIEL J. ESCOBAR
• 金额: $ 45万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7090169
• 关键词: behavioral /social science research tag; blood cell count; clinical research; critical care; decision making; diagnosis design /evaluation; diagnosis procedure safety; disease /disorder onset; disease /disorder proneness /risk; epidemiology; gestational age; health services research tag; human data; infant mortality; model design /development; neonatal intensive care; newborn human (0-6 weeks); patient care management; preeclampsia; respiratory distress syndrome of newborn; septicemia

DESCRIPTION (provided by applicant): Confirmed neonatal bacterial infections occur in 1-5 per 1000 live births. However, in the US about 10-20 percent of newborns have "sepsis work-ups" done, and 4-10 percent receives systemic antibiotics. Textbooks recommend antibiotic therapy for infants with definite signs of sepsis, meningitis, shock, or respiratory failure. They do not provide evidence-based guidance for the evaluation and management of two common groups of term or near-term newborns: 1) infants with maternal risk factors for bacterial infection (e.g., chorioamnionitis) with no symptoms or who have presentations that are considered equivocal, and 2) infants with respiratory distress, which occurs in approximately 2-3 percent of term and near-term infants. Clinicians evaluating term or near term infants must make 3 decisions: 1) whether to obtain laboratory tests; 2) whether to treat with antibiotics, and 3) whether to transfer the infant to a tertiary care center. We propose to improve the evaluation and management of newborns >= 34 weeks gestation at risk for bacterial infection and/or critical illness by developing an evidence-based approach to estimating probabilities relevant to each of these decisions. We will integrate gestational age-specific prior probabilities with likelihood ratios for maternal risk factors, clinical signs, and age-specific laboratory results. To achieve this goal, we have these Specific Aims: 1) To perform a nested case-control study to quantify maternal and infant clinical risk factors for early onset bacterial infection; 2) To perform a retrospective cross-sectional study to estimate likelihood ratios for early onset bacterial infection for components of the complete blood count (CBC, the most common diagnostic test in this setting), using data from more than 40,000 CBCs and blood cultures from 14 hospitals; and (3) To perform a nested case control study to develop a quantitative model to estimate the probability of newborns >= 34 weeks gestation developing a critical illness (defined by life-threatening arterial blood gas results) based on clinical findings and the results of laboratory tests, including arterial blood gases. To achieve these aims, we will analyze paper and electronic records from 340,000 newborns >= 34 weeks gestation born from 1998 to 2005 at 14 hospitals in Northern California and Boston. Our project builds on considerable development work conducted by investigators at Kaiser Permanente's Division of Research, the University of California, San Francisco, and the Harvard Newborn Medicine Program.

描述（由申请方提供）：每1000例活产婴儿中有1-5例发生确诊的新生儿细菌感染。然而，在美国，大约10- 20%的新生儿进行了“败血症检查”，4- 10%的新生儿接受了全身抗生素治疗。教科书建议对有明确败血症、脑膜炎、休克或呼吸衰竭迹象的婴儿进行抗生素治疗。他们没有为两组常见的足月或近足月新生儿的评估和管理提供循证指南：1）具有细菌感染母体风险因素的婴儿（例如，绒毛膜炎），没有症状或有被认为是模棱两可的表现，和2）婴儿呼吸窘迫，这发生在约2- 3%的足月和近足月婴儿。评估足月或近足月婴儿的临床医生必须做出3个决定：1）是否进行实验室检查; 2）是否使用抗生素治疗; 3）是否将婴儿转移到三级护理中心。我们建议通过开发一种基于证据的方法来估计与这些决策相关的概率，来改善对妊娠≥ 34周有细菌感染和/或危重疾病风险的新生儿的评估和管理。我们将整合孕龄特异性先验概率与母体风险因素、临床体征和特定年龄实验室结果的似然比。为了实现这一目标，我们有以下具体目标：1）进行巢式病例对照研究，以量化母婴早发性细菌感染的临床危险因素; 2）进行回顾性横断面研究，以估计全血细胞计数组分的早发性细菌感染的似然比。（CBC，在这种情况下最常见的诊断测试），使用来自14家医院的40，000多个CBC和血培养的数据;（3）采用巢式病例对照研究方法，建立一个定量模型来估计孕34周以上新生儿发生危重病的概率（由危及生命的动脉血气结果定义）基于临床发现和实验室检查结果，包括动脉血气。为了实现这些目标，我们将分析1998年至2005年在北方加州和波士顿的14家医院出生的340，000例妊娠≥ 34周的新生儿的纸质和电子记录。我们的项目建立在凯撒永久研究部、加州大学旧金山弗朗西斯科和哈佛新生儿医学项目的研究人员进行的大量开发工作的基础上。