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临床试验/NCT01126372
NCT01126372已完成不适用

Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease

University of Utah1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年5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
6
试验地点
1
主要终点
Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC.

研究概览

简要总结

Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow through a patent ductus arteriosus can cause intestinal ischemia and compromise the gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very least, feeding problems. Predicting which infants with CHD will develop NEC will potentially decrease the severity of disease if interventions were started earlier.

Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels in tissues such as brain, kidney, and as recently reported, intestine. This study will test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe. NIRS probes will be placed on the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be recorded prospectively and continuously with the clinical care team blinded to the data. The development of NEC and significant feeding problems will then be correlated with the regional oxygen saturations to determine whether decreased intestinal oxygen saturations predicted early signs and symptoms of NEC.

We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of this research will be provided partially by Somanetics, the manufacturer of the INVOS regional oxygen saturation monitors. They will, however, have no control over the data generated by this study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • >/+ 30 and 0/7 weeks gestation age at birth
  • Anticipated time to surgical repair is > 7 days
  • Meets criteria for management via the PCMC CHD feeding protocol

排除标准

  • Any extracardiac major congenital anomalies

结局指标

主要结局

Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC.

时间窗: 2 months

Using NIRS to test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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