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: 7290973
• 负责人: GABRIEL J. ESCOBAR
• 金额: $ 43.7万
• 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/7290973
• 关键词: Address; Age; Ambulances; Antibiotic Therapy; Antibiotics; Bacterial Infections; Biometry; Birth; Blood; Blood gas; Boston; California; Caring; Cerebrospinal Fluid; Chest; Clinical; Collaborations; Communicable Diseases; Complete Blood Count; Critical Illness; Cross-Sectional Studies; Data; Deterioration; Development; Diagnostic tests; Electronics; Environmental air flow; Epidemiology; Epidural Anesthesia; Evaluation; Extracorporeal Membrane Oxygenation; Federal Government; Frequencies; Funding; Gestational Age; Goals; Healthy People 2010; Helicopter; Hospitals; Hour; Infant; Infant Mortality; Infection; Infection of amniotic sac and membranes; Joints; Laboratories; Life; Literature; Live Birth; Maternal and Child Health; Medical; Medicine; Meningitis; Modeling; Morbidity - disease rate; Neonatal; Neonatal Intensive Care Units; Neonatology; Nested Case-Control Study; Newborn Infant; Paper; Patient observation; Population; Pre-Eclampsia; Pregnancy; Probability; Process; Recommendation; Records; Research; Research Personnel; Respiratory Failure; Respiratory distress; Risk; Risk Factors; Sampling; San Francisco; Sepsis; Shock; Symptoms; Testing; Textbooks; Triage; Universities; Week; Work; Yin; base; case control; design; early onset; improved; inhaled nitric oxide; neutrophil; programs; tertiary care

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（由申请人提供）：每 1000 名活产儿中就有 1-5 人发生确诊的新生儿细菌感染。然而，在美国，大约 10-20% 的新生儿接受了“脓毒症检查”，4-10% 接受全身抗生素治疗。教科书建议对出现败血症、脑膜炎、休克或呼吸衰竭明确症状的婴儿进行抗生素治疗。它们没有为评估和管理两类常见的足月或近足月新生儿提供基于证据的指导：1）具有细菌感染（例如绒毛膜羊膜炎）母体危险因素但无症状或表现被认为模棱两可的婴儿；2）患有呼吸窘迫的婴儿，这种情况发生在足月和近足月婴儿中约 2-3%。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，以及 3) 是否将婴儿转至三级护理中心。我们建议通过开发基于证据的方法来估计与每个决策相关的概率，从而改善对妊娠 34 周以上有细菌感染和/或危重疾病风险的新生儿的评估和管理。我们将把特定孕龄先验概率与孕产妇危险因素、临床体征和特定年龄实验室结果的似然比相结合。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，量化母婴早发细菌感染的临床危险因素； 2) 使用来自 14 家医院 40,000 多个 CBC 和血培养的数据，进行一项回顾性横断面研究，估计全血细胞计数（CBC，这种情况下最常见的诊断测试）各组成部分的早发细菌感染的可能性比； (3) 进行巢式病例对照研究，建立定量模型，根据临床发现和实验室检查结果（包括动脉血气分析）估计妊娠 34 周以上的新生儿发生危重疾病（由危及生命的动脉血气分析结果定义）的概率。为了实现这些目标，我们将分析 1998 年至 2005 年在北加州和波士顿 14 家医院出生的 340,000 名妊娠 34 周以上的新生儿的纸质和电子记录。我们的项目建立在凯撒医疗机构研究部、加州大学旧金山分校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。