Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely-Low-Birth-Weight Infants
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 220
- 试验地点
- 13
- 主要终点
- Death or moderate to severe bronchopulmonary dysplasia
研究概览
简要总结
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge. The infants' neurodevelopment was evaluated at 18-22 months corrected age.
详细描述
Chronic lung disease (CLD), also known as bronchopulmonary dysplasia (BPD), in very premature infants has been associated with mechanical ventilation and relative adrenal insufficiency.
This multicenter clinical trial tested whether minimal ventilation decreases death or BPD. Infants with birth weight 501g to 1000g and mechanically ventilated before 12 hours were randomly assigned to minimal ventilation (partial pressure of carbon dioxide [PCO(2)] target >52 mm Hg) or routine ventilation (PCO(2) target <48 mm Hg) and a tapered dexamethasone course or saline placebo for 10 days, using a 2 x 2 factorial design. The primary outcome was death or BPD at 36 weeks' postmenstrual age. Blood gases, ventilator settings, and FiO2 were recorded for 10 days; complications and outcomes were monitored to discharge.
The trial was terminated by the Steering Committee when the interim analysis for the Data Safety and Monitoring Committee showed a higher rate of spontaneous gastrointestinal perforations in the dexamethasone-treated infants.
Neurodevelopment was assessed at 18-22 months postmenstrual age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Minutes 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 12 hrs of age and less than 10 days chronologic age
- •501-1000 gm
- •Intubated and mechanically ventilated before 12 hrs
- •Indwelling vascular catheter
- •Infants 751-100 gm must be receiving FiO2 greater than 0.30 and have received at least 1 dose of surfactant at randomization
- •Parental consent
排除标准
- •Major congenital anomaly
- •Symptomatic non-bacterial infection
- •Permanent neuromuscular conditions that affect respiration
- •Terminal illness (defined as pH values less than 6.8 for more than 2 hours or persistent bradycardia associated with hypoxia for more than 2 hours)
- •Use of postnatal corticosteroids
研究组 & 干预措施
Routine ventilation without Dexamethasone
干预措施: Placebo (Drug)
Minimal ventilation with Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and early stress dose dexamethasone therapy
干预措施: Minimal mechanical ventilation management (Procedure)
Minimal ventilation with Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and early stress dose dexamethasone therapy
干预措施: Dexamethasone (Drug)
Minimal Ventilation without Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and no dexamethasone therapy
干预措施: Minimal mechanical ventilation management (Procedure)
Minimal Ventilation without Dexamethasone
Minimal ventilator support strategy (permissive hypercapnia) and no dexamethasone therapy
干预措施: Placebo (Drug)
Routine ventilation with Dexamethasone
干预措施: Routine mechanical ventilation management (Procedure)
Routine ventilation with Dexamethasone
干预措施: Dexamethasone (Drug)
Routine ventilation without Dexamethasone
干预措施: Routine mechanical ventilation management (Procedure)
结局指标
主要结局
Death or moderate to severe bronchopulmonary dysplasia
时间窗: 36 weeks postmenstrual age
次要结局
- Deafness(18-22 months corrected age)
- Death(18-22 months corrected age)
- Mechanical ventilation(36 weeks postmenstrual age)
- Pulmonary interstitial emphysema(36 weeks postmenstrual age)
- Pneumothorax(36 weeks postmenstrual age)
- Open-label steroids(36 weeks postmenstrual age)
- Reintubation(36 weeks postmenstrual age)
- Intracranial hemorrhage (IVH) III or IV(36 weeks postmenstrual age)
- Periventricular leukomalacia(36 weeks postmenstrual age)
- Necrotizing enterocolitis(36 weeks postmenstrual age)
- Duration of oxygen supplementation(36 weeks postmenstrual age)
- Duration of ventilation(36 weeks postmenstrual age)
- Length of hospitalization(Hospital discharge)
- Death or neurodevelopmental impairment(18-22 months corrected age)
- Neurodevelopmental impairment(18-22 months corrected age)
- Cerebral palsy(18-22 months corrected age)
- Bilateral blindness(18-22 months corrected age)
- Bayley Scales of Infant Development-Revised II Psychomotor Developmental Index (PDI)(18-22 months corrected age)
- Rehospitalizations(18-22 months corrected age)