2023-508785-16-00招募中3 期
Efficacy of dexmedetomidine versus midazolam sedation on extubation time in mechanically ventilated preterm infants: a randomized controlled multicenter trial (DEXPRE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 9
- 主要终点
- Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
研究概览
简要总结
To compare the efficacy of dexmedetomidine-based sedation versus midazolam-based sedation in very preterm neonates.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient admitted in NICU
- •Randomization criteria 2 : elective sedation (acceptable delay between the decision to sedate and the administration of the sedative agent),
- •Randomization criteria 3 : presence or plan of a venous access,
- •Randomization criteria 4 : no medical contraindication related to the administration of dexmedetomidine or midazolam,
- •Holder(s) of parental authority must sign the written or electronic informed consent
- •Holder(s) of parental authority must sign the written or electronic informed consent
- •Randomization criteria 5 : no concomitant use of curare agent
- •randomization criteria 6 : no previous extubation within 7 days
- •Randomization criteria 7 : no Clonidine treatment
- •randomisation criteria 7 : no hemodynamic instability
- •randomisation criteria 8 : no palliative care
- •Gestational age at birth < 32 weeks of gestation (WG),
- •Corrected gestational age <45 weeks of gestation (WG)
- •Randomization criteria 1 : indication for sedation in the context of invasive mechanical ventilation
排除标准
- •Polymalformative syndrome
- •Palliative care,
- •Inclusion in another clinical trial on medicinal products, clinical investigation protocol concerning a medical device or interventional protocol not concerning a health product.
- •Clonidine treatment
- •Parents who don't understand French
结局指标
主要结局
Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
Time-to-extubation after discontinuation of dexmedetomidine-based sedation versus discontinuation of midazolam-based sedation in very preterm neonates.
次要结局
- Administration of opioid agents during the period of interest, i.e., from the start of treatment (DEX or midazolam) until extubation
- Time (in hours) between start of sedation and achievement of a normal Comfort B score (ie. between 11 and 17).
- Intubation rate at 24 hours after extubation.
- Proportion of patients with at least one value of the Finnegan score > 8 from within 3 days after extubation.
- Hemodynamic and respiratory adverse event from start of the sedation until 84 h after the sedative is stopped defined as: bradycardia, hemodynamic instability, desaturation <85% despite optimization of mechanical ventilation, reintubation
- In-hospital mortality
- Severe neonatal morbidity
研究者
Dr Clément CHOLLAT
Scientific
Assistance Publique Hopitaux De Paris
研究点 (9)
Loading locations...
相似试验
已完成
不适用
Procedural Sedation in Renal Sympathetic DenervationNCT07293273Ebru Girgin Dinc142
招募中
3 期
Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammation (PET-DEXDOCOVID)2024-511898-30-00Assistance Publique Hopitaux De Paris72
进行中（未招募）
4 期
Continuous Epidural With Dexmedetomidine Adjuvant in Gynecologic LaparotomyNCT07292324Udayana University62
招募中
3 期
« Effect of sedative and anxiolytic sedation on children experience after general anesthesia »
PEDIA_prem study.2022-501124-23-00Centre Hospitalier Universitaire De Montpellier1,000
招募中
不适用
Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower ExtremityNCT07276867National Cancer Institute, Egypt58