Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Peak electrical activity of the diaphragm (Edi peaks)
研究概览
简要总结
This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Minute 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
- •Infant must be stable on NAVA for at least 24 hours prior to the study
排除标准
- •Infants with congenital heart disease (CHD)
- •Infants with persistent pulmonary hypertension (PPHN)
- •Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.
结局指标
主要结局
Peak electrical activity of the diaphragm (Edi peaks)
时间窗: From enrollment in study to end of study (a total of twelve hours)
Height of Edi signal in uV
Minimum electrical activity of the diaphragm (Edi mins)
时间窗: From enrollment in study to end of study (a total of twelve hours)
Lowest of Edi signal in uV
Number of apenic events
时间窗: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant ceases to breath for \>5 seconds
Number of bradycardia events
时间窗: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's heart rate drops \<100bpm sustained for \>5s
Number of desaturation events
时间窗: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's oxygen saturation drops \<85% sustained for \>5s
次要结局
未报告次要终点
研究者
Nada Darwish
Neonatal-Perinatal Medicine Fellow
Milton S. Hershey Medical Center