A Prospective Study of Diaphragmatic Electrical Activity in Preterm Infants as a Means to Predict Extubation Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Edi_avg just prior to extubation in infants with extubation success and those with extubation failure
研究概览
简要总结
Mechanical ventilation used to support the sick newborn infant is associated with many complications including the development of chronic lung disease. Limiting prolonged invasive ventilation remains an important strategy to decrease lung injury and prevent chronic lung disease. Currently, there is no objective measure available to predict readiness for removal of the endotracheal tube ("extubation") and discontinuing mechanical ventilation in this fragile population.
The investigators propose to predict extubation success by evaluating the electrical activity of the diaphragm (Edi), which provides important information about the "drive" to breathing coming from the brain and the function of the diaphragm, two essential factors determining extubation readiness and success.
详细描述
In this observational study, very low birth weight preterm infants with RDS who require mechanical ventilation in first 24 hour of life will be recruited. A size appropriate nasogastric tube with multiple array of electrodes (Edi catheter) will be inserted in each eligible infant. The average EdI (Edi_avg) will be measured during mechanical ventilation just before extubation. All infants will be extubated to non-invasive positive pressure ventilation (NIPPV or CPAP) delivered through nasal cannula
The specific aim is to determine whether there is a relationship between Edi_avg before extubation and the extubation success in a sample of preterm infants with respiratory distress syndrome (RDS). We hypothesize that Edi-avg of infants with successful extubation will be significantly different from the infants who fail extubation
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
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants less than 35 week gestation, requiring intubation and mechanical ventilation for respiratory distress in the first 24 hours of life
排除标准
- •Infants with a non-intact esophagus (e.g tracheal-esophageal fistula or atresia), a non-functional diaphragm (e.g. phrenic nerve palsy), severe intracranial hemorrhage or structural CNS abnormality, severe birth asphyxia and critically sick infant needing paralysis or deep sedation.
结局指标
主要结局
Edi_avg just prior to extubation in infants with extubation success and those with extubation failure
时间窗: From time of initial intubation to 3 days after extubation from mechanical ventilator
Edi_avg prior to extubation will be compared between the group with successful extubation and those with failed extubation( i.e.needing re-intubation within 3 days of extubation)
次要结局
- Study the trends of Edi_avg in preterm infants with respiratory distress syndrome requiring mechanical ventilation in first seven days of life.(First seven days of life)
研究者
Neetu Singh
Assistant Professor of Pediatrics
Dartmouth-Hitchcock Medical Center