Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia With Early Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Response to inhaled nitric oxide
研究概览
简要总结
This multicenter, prospective, single-arm study aims to evaluate the efficacy of inhaled nitric oxide (iNO) in neonates with congenital diaphragmatic hernia (CDH) and early pulmonary hypertension. Short-term treatment response will be assessed by the changes in oxygenation index and other parameters including echocardiographic parameters at predefined intervals.
详细描述
Congenital diaphragmatic hernia (CDH) is a life-threatening congenital anomaly characterized by pulmonary hypoplasia and persistent pulmonary hypertension of the newborn (PPHN). Despite advances in neonatal intensive care, management of pulmonary hypertension remains a major challenge, and the role of inhaled nitric oxide (iNO) in this population is still controversial.
This study evaluates the therapeutic efficacy and physiological responses to iNO in late preterm (34 weeks of gestational age or more) or term neonates with Bochdalek-type CDH and severe pulmonary hypertension who require mechanical ventilation but are not placed on ECMO within 14 days of life.
iNO will be initiated at 20 ppm, and serial measurements of oxygenation index, arterial blood gas, vital signs, cerebral oxygen saturation (NIRS), and echocardiographic indices will be performed to evaluate the short-term treatment response.
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
- 1 Minute 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bochdalek type congenital diaphragmatic hernia
- •Gestational age at 34 weeks or more and within 14 days after birth
- •Hypoxic respiratory failure and pulmonary hypertension
排除标准
- •Combined congenital heart disease requiring neonatal intervention or surgery
- •Previous treatment of pulmonary vasodilators including inhaled nitric oxide
- •on ECMO treatment
研究组 & 干预措施
Inhaled Nitric Oxide
Administration of inhaled NO in newborn infants with CDH approaching predefined criteria of pulmonary hypertension and hypoxic respiratory failure
干预措施: Inhaled Nitric Oxide (Drug)
结局指标
主要结局
Response to inhaled nitric oxide
时间窗: At 30-60 minutes after administration of inhaled nitric oxide.
Participants were categorized as responders if their oxygenation index or FiO2 improved by more than 20% from baseline after administration of inhaled nitric oxide for at least 30 minutes.
次要结局
未报告次要终点
研究者
Byong Sop Lee
Professor, Department of Pediatrics
Asan Medical Center