NCT03803657撤回不适用
Comparison of Measured Caloric Expenditure Versus Administered Calories in Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Average caloric expenditure
研究概览
简要总结
The investigators have created and validated a device that allows us to accurately measure how many calories a baby consumes every day. The purpose of this study is to compare how many calories a baby consumes with how many calories are provided in a population of newborn infants and children. This may help clinicians to better understand how to feed babies during times of critical illness.
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
- •Mechanically ventilated neonates, infants and children, regardless of age, up to 10 kg
- •Inpatients in the cardiac (8S), medical-surgical (7S) or neonatal (7N) intensive care unit
- •Assent of patient's intensive care attending physician
- •Written parental informed consent.
- •Patient on conventional mechanical ventilation on a Servo I or Servo U ventilator with fraction of inspired oxygen <80%.
排除标准
- •Clinically significant tracheo-esophageal fistula
- •Measured ETT leak >20% (i.e. difference between inspiratory and expiratory tidal volumes)
- •Patient on high frequency oscillatory ventilation or high frequency jet ventilation.
结局指标
主要结局
Average caloric expenditure
时间窗: through study completion, an average of 3 days
Number of calories consumed
次要结局
未报告次要终点
研究者
John Kheir
Staff physician
Boston Children's Hospital
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