Evaluation of Sedation in Newborns - a Prospective, Controlled, Observer Blinded Clinical Trial in 67 Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG)
研究概览
简要总结
Neonates treated on Neonatal Intensive Care Units are often critically ill, subject to numerous painful procedures and often dependent on mechanical ventilation. Mechanical ventilation as well as painful conditions require a sufficient analgesia and or an accurately regulated sedation. Newborns incapable of self-report are therefore dependent on the assessment of the infants level of pain and sedation by the treating team.
The aim of this prospective, controlled, observer-blinded clinical trial is to compare the performance of two EEG based methods and a clinical sedation scale to measure the level of sedation in neonates. The Bispectral-Index (BIS) and the amplitude-integrated EEG (aEEG) are compared with the Neonatal Pain and Sedation Scale (N-PASS). We hypothesize a correlation between the clinical sedation score (N-PASS), the bispectral index (BIS) and the amplitude-integrated EEG (aEEG). Fifty-two mechanically ventilated term neonates and fifteen control patients are enrolled and observed for up to 72h.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •newborns with a corrected gestational age ≧ 37 and ≦ 44 weeks of gestation
排除标准
- •congenital malformations
- •chromosomal aberrations
- •brain abnormalities
- •severe cerebral hemorrhage (grade III-IV)
- •cystic periventricular leukomalacia
- •infections of the central nervous system
结局指标
主要结局
Correlation between clinical sedation score (N-PASS) and the bispectral index (BIS) and the amplitude-integrated EEG (aEEG)
时间窗: 72 hours
The BIS-Monitoring is continuously recorded for up to 72 hours.A aEEG is recorded once daily for a minimum of four hours. aEEG and BIS are derived continuously for two head electrodes. Every 3-4 hours the N-PASS is evaluated by a nurse and recorded in the patient documentation system.
次要结局
- Differences of the values of the BIS, the aEEG and the sedation scores in the group of mechanically ventilated / sedated newborns and the group of non-ventilated /non-sedated neonates(72 hours)
- Relationship between daily doses of sedatives / analgesics and sedation levels(72 hours)