Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Death or Bronchopulmonary Dysplasia
研究概览
简要总结
Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:
- decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death
- shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect
详细描述
Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia.
Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control.
During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GA<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy
- •GA<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days
排除标准
- •lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm)
- •active pulmonary hemorrhage, unevaluated pneumothorax
- •preexisting bilateral grade 3-4 intraventricular hemorrhage
- •a platelet count <100*10^9/l
- •an expected duration of ventilation of less than 48 hours
研究组 & 干预措施
inhaled nitric oxide
The preterm infants in the experimental group inhaled nitric oxide
干预措施: Nitric Oxide (Drug)
oxygen
The preterm infants enrolled but subjected to routine respiratory support.
干预措施: respiratory support (Device)
结局指标
主要结局
Death or Bronchopulmonary Dysplasia
时间窗: Before discharge or at 36 weeks post-conceptional age
the incidence of death before discharge or BPD at 36 weeks post-conceptional age
次要结局
- Intraventricular Hemorrhage Grade III and IV(At 36 weeks post-conceptional age)
- Days on assisted ventilation(Before discharge)
- Length of oxygen therapy(Before discharge)
- Retinopathy of prematurity(Before discharge)
- Cost of hospital and NICU stay(Before discharge)