The PALISA Study - Pain Assessment During Less-Invasive-Surfactant-Administration
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
- Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
研究概览
简要总结
Primary aims of the study are to evaluate the feasibility of Skin conductance (SC) measurements and its correlation to Neonatal Pain and Distress Scale (N-PASS) - scores during the Less-Invasive-Surfactant-Administration (LISA)-procedure in preterm infants. Secondary aims are to evaluate the effect of LISA on the general stress-level in preterm infants with respiratory distress syndrome.
The assessment of pain and stress with SC measurement in addition to the subjective assessment with N-PASS may provide more conclusive data on the sensation of pain or stress during the LISA procedure and therefore the necessity of analgosedation. Therefore, this study might help to identify those infants in need for analgosedation, which would allow an individualized approach in the future.
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
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants ≥27 0/7 weeks of gestation at birth
- •Need for surfactant therapy via LISA according to the local standard operating procedure
- •≥27 0/7 weeks of gestation,
- •within first 48 hours of life
- •FiO2 ≥0.30 to maintain SpO2 ≥90% for 15 min,
- •non-invasive respiratory support with PEEP 6-8 cmH2O
- •consent of attending NICU staff for videorecording
排除标准
- •Primary intubation in the delivery room
- •Severe congenital malformation or other conditions requiring immediate endotracheal intubation
- •Insufficient language skills (German or English) of the parents to understand and consent the participation in the study.
研究组 & 干预措施
Preterm infants with minimal gestational age of 27 weeks requiring LISA
LISA will be preformed according to our local standard protocol while measuring skin conductance via a specific monitor. At the same time a video is recorded for later unblinded and blinded N-PASS assessment.
干预措施: Skin Conductance (SC) Measurement (Other)
Preterm infants with minimal gestational age of 27 weeks requiring LISA
LISA will be preformed according to our local standard protocol while measuring skin conductance via a specific monitor. At the same time a video is recorded for later unblinded and blinded N-PASS assessment.
干预措施: Video Recording (Other)
结局指标
主要结局
Median peaks per second at prespecified time-points adjusted for median peaks per second at baseline
时间窗: 2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA
The prespecified time-points are: 1. baseline: before starting of interventions (2 minutes recording without any intervention); 2. insertion of nasopharyngeal tube; 3. insertion of laryngoscope for visualization of the vocal cords; 4. insertion of LISA catheter 5. administration of surfactant 6. removal of catheter 7. 5 minutes after removal of catheter (2 minutes recording without any intervention) 8. 1 hour (±10 minutes) after LISA (2 minutes recording without any intervention)
次要结局
- Absolute number of bradycardia(During LISA procedure)
- Median Neonatal Pain, Agitation and Sedation Scale (N-PASS) at prespecified time-points, adjusted for median N-PASS at baseline(2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA)
- Difference in maximum peaks per second before and after blunt surfactant reflux(During LISA procedure)
- Difference in SpO2/FiO2-ratio between baseline and prespecified time-points as listed above.(2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA)
- Absolute number of blunt surfactant reflux(During LISA procedure)
- Difference in maximum peaks per second before and after apnea(During LISA procedure)
- Difference in maximum peaks per second before and after bradycardia(During LISA procedure)
- Difference in median peaks per second during 20-second interval before and after bradycardia(During LISA procedure)
- Absolute number of apneas(During LISA procedure)
- Absolute number of desaturations(During LISA procedure)
- Absolute number of arterial hypotension(During LISA procedure)
- Difference in maximum peaks per second before and after desaturation(During LISA procedure)
- Difference in median peaks per second during 20-second interval before and after desaturation(During LISA procedure)
- Difference in median peaks per second during 20-second interval before and after arterial hypotension(During LISA procedure)
- Difference in median peaks per second during 20-second interval before and after blunt surfactant reflux(During LISA procedure)
- Difference in median peaks per second during 20-second interval before and after apnea(During LISA procedure)
- Difference in maximum peaks per second before and after arterial hypotension(During LISA procedure)
- Intubation <72 hours after the LISA procedure(Within 72 hours after LISA)
- Incidence of intraventricular hemorrhage(72 hours after LISA)
- Difference of SpO2/FiO2-ratio compared to skin conductance peaks per second(2 minutes before LISA, 5 minutes after removal of catheter, 60 Minutes after LISA)
- LISA failure(Within 24 hours after LISA)
- Air-leaks <72 hours after the LISA procedure(Within 72 hours after LISA)
- Difference in heart-rate between baseline and prespecified time-points as listed above.(2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA)
- Difference in oxygen saturation between baseline and prespecified time-points as listed above.(2 minutes before LISA, during LISA, 1 hour (±10 minutes) after LISA)