Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
研究概览
简要总结
The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.
详细描述
All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than or equal to 32 weeks gestation;
- •Less than or equal to 1250 g;
- •Mechanical ventilation;
- •Echocardiographic findings of PDA with left to right shunting;
- •Medical judgement of neonatologist for medical treatment;
排除标准
- •Urine output less than 1 ml/k/hr over previous 12 hours;
- •Serum creatinine greater than 1.5 mg/dL;
- •Platelet count less than 100,000 per cubic mm;
- •Significant skin breakdown at sensor areas;
- •Significant congenital anomalies
- •Intraventricular hemorrhage greater than or equal to grade III
结局指标
主要结局
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
时间窗: 48-72 hours
Measure oxygenation/blood flow to brain during PDA treatment
时间窗: Study period
次要结局
- Oxygenation during/after treatment with PDA therapy(Study period)