Predicting Respiratory Distress Syndrome in Neonates Delivered in a Lower-Level NICU Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.
研究概览
简要总结
The purpose of this study is to analyze the gastric fluid aspirated from the stomachs of neonates receiving routine post-delivery care to predict the need for prolonged respiratory support (>6 hours of life).
详细描述
The source of the gastric aspirates will be the medical waste generated through the routine care of neonates whose deliveries are attended by the Mayo Clinic neonatal resuscitation team.
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
- 32 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both of the following:
- •Neonates born at 32 completed weeks gestational age or older whose deliveries are attended by the neonatal resuscitation team and for whom routine gastric suctioning is indicated
- •Neonates whose parents actively accepted or did not actively decline the Minnesota Research Authorization.
排除标准
- •Any one of the following:
- •Neonates with known or suspected congenital anomalies
- •Neonates for whom only comfort measures are planned or possible at time of delivery
- •Neonates whose parents actively declined the Minnesota Research Authorization.
- •Neonates with other identifiable causes of respiratory distress including pneumothorax, meconium aspiration syndrome, or pneumonia.
结局指标
主要结局
Performance of the algorithmic prediction of the need for prolonged respiratory support, defined as >6 hours of life.
时间窗: 1 years
Calculated sensitivity, specificity, positive- and negative-predictive values of the predicted outcomes compared to actual patient outcomes.
Accuracy of algorithmic prediction of negative cases of Respiratory Distress Syndrome
时间窗: 2 years
Total proportion of true negatives as determined by the digital point-of-care device algorithm predicting no diagnosis of Respiratory Distress Syndrome and the clinician does not diagnosis Respiratory Distress Syndrome. Reported as a calculation of # true negatives / (# true negatives + # false negatives).
次要结局
未报告次要终点
研究者
William A. Carey
Principal Investigator
Mayo Clinic