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: 7605902
• 负责人: ANN STARK
• 金额: $ 1.24万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-15 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605902
• 关键词: Academy; Age; American; Benign; Bilirubin; Birth; Clinical; Clinical assessments; Cohort Studies; Computer Retrieval of Information on Scientific Projects Database; Condition; 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; day; 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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 60%的健康新生儿有临床黄疸，伴有血清总胆红素（TSB）浓度升高。 大多数良性的结果，但未经治疗的极高TSB水平的婴儿可能会发展核黄疸，这是一种由于胆红素毒性引起的神经破坏性疾病。 TSB水平通常在3至5天内达到峰值，通常在常规出院后。 出院前评估后续高胆红素血症的风险应有助于适当的随访和管理;然而，评估该风险的最有效策略尚不清楚。 美国儿科学会推荐的两种选择是分析胆红素，表示为特定小时的字母组合上的风险区和/或评估临床风险因素。 这些策略单独使用或组合使用的相对准确性尚不清楚。 这项前瞻性多中心队列研究在大量不同种族的美国人群中检验了以下假设：1）出院前（年龄<72小时）胆红素危险区绘制在小时特异性列线图上比单独使用临床危险因素更准确地预测重度高胆红素血症的风险;和2）联合使用出院前胆红素危险区和临床危险因素比单独使用任一种方法更准确地预测显著的高胆红素血症。 我们将测量2000名健康新生儿在24+6小时、36至48小时（出院前）、3至5天和7至14天的系列胆红素水平（TSB和经皮，TcB）。 前瞻性识别已知的临床风险因素、出院前TSB/TcB水平和出院前TcB水平的增量，将用于制定后续重度高胆红素血症（> 95百分位数，以小时计）和光疗需求的预测规则。 确定最佳的出院前评估后续高胆红素血症的风险，将确保从婴儿的出生医院到家庭的安全过渡，并可能防止核黄疸。