MULTICENTER OBSERVATIONAL STUDY TO EVALUATE STRATEGIES TO IDENTIFY INFANTS AT

多中心观察研究评估识别婴儿的策略

• 批准号: 7950612
• 负责人: ANN STARK
• 金额: $ 0.02万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7950612
• 关键词: Academy; Age; American; Benign; Bilirubin; Birth; Clinical; Clinical Research; Clinical assessments; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Ensure; Funding; Grant; Home environment; Hospitals; Hour; Hyperbilirubinemia; Infant; Institution; Kernicterus; Measures; Methods; Newborn Infant; Nomograms; Observational Study; Outcome; Pediatrics; Phototherapy; Population; Relative (related person); Research; Research Personnel; Resources; Risk; Risk Assessment; Risk Factors; Serum; Source; Testing; Toxic effect; United States National Institutes of Health; follow-up; prevent; prospective

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Sixty percent of otherwise healthy newborns have clinicaljaundice associated with increased concentration of total serum bilirubin (TSB). The outcome for the majority benign, but infants with untreated extremely high TSB levels can develop kernicterus, a neurologically devastating condition due to bilirubin toxicity. TSB levels typically peak at age 3 to 5 days, usually after routine hospital discharge. Assessment before discharge of the risk for subsequent hyperbilirubinemia should facilitate appropriate follow-up and management; however the most effective strategy to assess this risk is unknown. Two options recommended by the American Academy of Pediatrics are analysis of bilirubin expressed as a risk zone on an hour-specific monogram and/or assessment of clinical risk factors. The relative accuracy of these strategies used alone or in combination is not known. This prospective multicenter cohort study tests the following hypotheses in a large racially diverse US population: 1) the pre-discharge (<72 hr of age) bilirubin risk zone plotted on an hour-specific nomogram more accurately predicts the risk of severe hyperbilirubinemia than the use of clinical risk factors alone; and 2) the combined use of pre-discharge bilirubin risk zone and clinical risk factors more accurately predicts significant hyperbilirubinemia than using either method alone. We will measure serial bilirubin levels (TSB and transcutaneous, TcB) in 2000 healthy newborns at age 24+6 hours, 36 to 48 hours (pre-discharge), 3 to 5 days, and 7 to 14 days. Prospective identification of known clinical risk factors, pre-discharge TSB/TcB levels and the increment in TcB levels prior to discharge will be used to develop prediction rules for the outcome of subsequent severe hyperbilirubinemia (>95th percentile for age in hours) and need for phototherapy. Identifying the optimal pre-discharge assessment for risk of subsequent hyperbilirubinemia will ensure a safer transition from the infant's birth hospital to home and may prevent kernicterus.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 60％的其他健康新生儿具有与总血清胆红素（TSB）浓度升高有关的临床jaundice。 大多数良性的结果，但是未经治疗的非常高的TSB水平的婴儿可以发展核，这是由于胆红素毒性而导致的神经学上具有破坏性的疾病。 通常在常规住院后，TSB水平通常在3至5天达到3至5天的峰值。 出院前评估随后的高胆红素血症的风险应促进适当的随访和管理；但是，评估这种风险的最有效策略尚不清楚。 美国儿科学会建议的两种选择是对胆红素的分析，该分析是在一个小时特定的会标和/或评估临床危险因素上作为风险区域表示的。 这些单独使用或组合使用的这些策略的相对准确性尚不清楚。 这项前瞻性多中心队列研究测试了大量种族多样化的美国人群中的以下假设：1）在一个小时特异性的命名图上绘制的胆红素风险区（年龄<72小时）（<72 hr）（<72 hr），可以更准确地预测，比单独使用临床风险因素的使用更准确地预测了严重的高脂蛋白的风险； 2）与单独使用任何两种方法相比，胆红素前风险区和临床风险因素的联合使用更准确地预测了明显的高胆红素血症。 我们将在2000年24+6小时，36至48小时（预分娩前），3至5天和7天的新生新生儿中测量2000年健康新生儿的系列胆红素水平（TSB和经皮，TCB）。 前瞻性鉴定已知的临床危险因素，预分泌物TSB/TCB水平以及出院前TCB水平的增长将用于制定预测规则，以确保随后严重的高胆红素血症的结果（小时年龄> 95个百分点）和需要光疗的预测规则。 确定最佳的入院前评估，以确保随后的高胆红素血症的风险，将确保从婴儿的出生医院到家的更安全过渡，并可能预防核。