跳至主要内容
临床试验/NCT01109277
NCT01109277已完成不适用

An Evidence-based Strategy for Assessing the Risk of Significant Neonatal Hyperbilirubinemia

University of Patras1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,500
试验地点
1
主要终点
Risk of significant hyperbilirubinemia assessed by an evidence-based strategy

研究概览

简要总结

Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.

Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (TcB) values could reliably predict significant neonatal hyperbilirubinemia.

Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from January 2008 to December 2010 will be reviewed.

The registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). TcB and TSB values are plotted on a hour-specific chart.

A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics 2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.

Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy threshold level according to the AAP 2004 guidelines

Statistics: Independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to develop the strategy. At each step, CHAID chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. Categories of each predictor are merged if they are not significantly different with respect to the dependent variable.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
1 Hour 至 15 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy term and late-preterm neonates

排除标准

  • Admission to the NICU

结局指标

主要结局

Risk of significant hyperbilirubinemia assessed by an evidence-based strategy

时间窗: Birth to 14th postnatal day

Risk for significant hyperbilirubinemia (defined as serum bilirubin values above the phototherapy threshold according to the American Academy of Pediatrics 2004 guidelines) assessed by a strategy which will combine clinical risk factors and non-invasive TcB measurements

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验