Dexmedetomidine for LISA Procedure in Preterm Infants: a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- effectiveness of dexmedetomidine in achieving sedation for LISA procedure
研究概览
简要总结
The investigators aim to evaluate: the effectiveness of dexmedetomidine for analgesia and sedation during LISA procedure, without compromising the respiratory drive; the safety of this drug on the preterm infant in a pilot study.
详细描述
Information will be given to parents of preterm babies <36 wGA upon their admission to the NICU (neonatal intensive care unit), and informed consent will be obtained as soon as possible. Eligible babies for LISA procedure (dyspneic and FiO2 > 0.30 on CPAP pressure of at least 6 cmH2O) undergo sedation with dexmedetomidine 1 mcg/kg, administered slowly iv in 10 minutes, together with non pharmacological techniques. After the step of sedation LISA is performed. Before/during and after the procedure pain will be assessed by the NIPS scale and the quality of intubation will be evaluated; then other events related to the procedure will be strictly collected for the first 24 hours. Babies will then be managed in usual NICU way and clinical data will be unregistered on respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 26 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm newborns between 26+0 and 36+6 weeks of gestation stratified in two groups: VLBWI 26-31+6and LBWI 32-36+
- •Respiratory distress syndrome requiring surfactant therapy
排除标准
- •Need for emergency intubation in the delivery room
- •Major congenital malformations (such as cardiopathies)
- •Chromosomic abnormalities
- •Fetal Hydrops
- •Hypercapnia: CO2 > 65 mmHg
- •Pneumothorax
- •Hemodynamic compromise
研究组 & 干预措施
Every preterm newborns 26+0 -36+6 wGA with RDS needing surfactant therapy
Every preterm newborns 26+0-36+6 wGA who undergoes LISA procedure will receive sedation with dexmedetomidine in order to evaluate its efficacy in achieving pain control and comfort.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
effectiveness of dexmedetomidine in achieving sedation for LISA procedure
时间窗: basal (before procedure), during and immediately after the procedure
evaluation of changes in Neonatal Infant Pain Scale (NIPS) score (0-2 points= no pain, 3-4 points = moderate pain; \> 4 = severe pain)
Safety of dexmedetomidine in sedating preterm infants
时间窗: 24 hours
evaluation of number of apneas ( \> 20 seconds or \< 20 seconds with bradycardia \< 100 bpm or desaturation ( SpO2 \< 85%)); number of severe apnea and bradycardia (defined by the American Academy of Pediatrics Guidelines as apnea \> 30 seconds and/or heart rate \< 60 beats/minute for more than 10 seconds); need for intubation.
次要结局
- Intubation conditions(during the procedure)
- number of laryngoscopies needed to perform LISA(during the procedure)
- The incidence of pneumothorax or selective administration of surfactant(24 hours after drug injection)
- Long term outcomes(at 40 weeks PMA)
- time needed to perform LISA(during the procedure)
- changes in ventilation mode(1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection)
- the evolution of cardiorespiratory parameters(1 min, 3 min, 5 min, 15 min, 30 min, 60 min and 120 min after the first drug injection)
- The incidence of drug adverse effects(24 hours after drug injection)
研究者
Paola Lago
Head of Neonatal Intensive Care Unit, Principal Investigator
University of Padova