Double blind, multicenter, randomized, controlled trial of dexmedetomidine vs placebo in premature neonates receiving invasive ventilation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 12
- 主要终点
- Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 h, whichever comes last.
研究概览
简要总结
To assess the effect of continuous intravenous infusion of dexmedetomidine vs placebo on the cumulative opioids’ doses (including continuous infusion and boluses) in ventilated premature neonates with an expected or effective duration of ventilation of at least 24h.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment and follow-up
- 盲法
- Double (Monitor, Investigator, Carer, Analyst, Subject)
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
- •Neonates with a gestational age at birth < 32 weeks of gestation and corrected gestational age < 32 weeks postmenstrual age
- •Invasively ventilated with an expected or effective duration of ventilation > 24h at inclusion
- •Under mechanical ventilation since less than 72h at inclusion
- •With parental consents
- •Affiliated to or benefiting from a social security system
排除标准
- •Previous inclusion in this trial
- •Hypersensitivity to the active substance or to any of the excipients contained in the medicine
- •Participation in another trial including analgesics or sedatives
- •Ongoing palliative care
- •Administration of dexmedetomidine or another alpha-2 agonist in the 96 previous hours
- •Hemodynamic compromise defined as any of: poor perfusion (increased capillary refill time, oliguria); hypotension defined as a mean blood pressure in mm Hg < postmenstrual age in weeks; ongoing inotropic treatment with dopamine or dobutamine ≥ 5 µg/kg/min, or any other inotropic drug at any dose, or need for more than one volume expansion (20 ml/kg) in the 6 previous hours
- •Pulmonary hypertension requiring pharmacological treatment
- •Heart rate <100 bpm
- •Hepatic impairment defined as alanine aminotransferase level > 2x normal upper limit
- •Known contra-indications to dexmedetomidine: hypersensitivity, atrioventricular block, acute cerebrovascular event
结局指标
主要结局
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 h, whichever comes last.
Cumulative dose of opioids (morphine, sufentanil, fentanyl) converted to equivalent morphine dose in µg/kg using fixed equipotency ratios based on national prescriptions habits, administered during the studied period defined as the time between the start of the investigational drug and the cessation of any opioid or of the investigational drug for at least 24 h, whichever comes last.
次要结局
- Pain and comfort outcomes: COMFORTneo pain and comfort scale, number of days with opioids and/or benzodiazepines, cumulative dose of midazolam (µg/kg), frequency of muscle blocker use;
- Opioids’ adverse effects: age at full enteral feeding, urinary retention, Finnegan neonatal withdrawal scale, duration of invasive ventilation, extubation failure at 3 and 7 days after extubation, unplanned extubation
- Dexmedetomidine’s tolerance: bradycardia (heart rate < 100/min for 5 consecutive minutes with SpO2> lower threshold for postmenstrual age), hypotension (mean arterial blood pressure in mmHg < postmenstrual age in weeks), anti-hypotensive treatments use
- Safety outcomes at discharge: in-hospital mortality, total duration of invasive and non-invasive ventilation, total duration of NICU and hospital stay, high-grade intraventricular hemorrhage, periventricular leukomalacia, secondary sepsis, treated patent ductus arteriosus, bronchopulmonary dysplasia at 36 weeks postmenstrual age, necrotizing enterocolitis, isolated intestinal perforation, treated retinopathy of prematurity.
- Long-term neurodevelopment using tests validated in French: Parent Report of Children's Abilities-Revised (PARCA-R) at age 2 and BMT-i (Batterie Modulable de Tests informatisée, or "computerized Adaptable Test Battery") at age 6
研究者
Xavier DURRMEYER
Scientific
Centre Hospitalier Intercommunal Creteil