The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 478
- 试验地点
- 40
- 主要终点
- Extubation failure
研究概览
简要总结
DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.
详细描述
Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. Ventilator induced lung injury (VILI) an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy.
Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Trial PIs are unaware of treatment allocation for individual subjects
入排标准
- 年龄范围
- 0 Days 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age of 23 0/7- 28 6/7 weeks at birth
- •Intubated in the first 7 days of life
- •Undergoing extubation following at least 12 hours of invasive mechanical ventilation
- •Post-natal age <32 weeks Post menstrual age at time of extubation
排除标准
- •Major congenital anomalies, including pulmonary hypoplasia
- •Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
- •Esophageal bleeding or other contraindication to NG/OG catheter placement
- •Current weight <500 grams (based on Edi catheter approval)
- •Study ventilator not available at time eligibility criteria are met
- •Planned surgery or invasive procedure within 5 days of extubation
- •Informed consent not provided
研究组 & 干预措施
NIV-NAVA
干预措施: NIV-NAVA (Device)
NS- NIPPV
干预措施: NS-NIPPV (Device)
结局指标
主要结局
Extubation failure
时间窗: within the first 5 days (120 hours) post extubation
Extubation failure is defined when an infant is on the allocated mode of respiratory support and meets any of the following 4 criteria: (1) Rise in FiO2 at least 20% from pre-extubation value for \>2 hours to maintain local SpO2 targets, (2) pH ≤7.20 or pCO2 ≥70mm Hg; (3) \>1 apneic event requiring positive pressure ventilation (PPV) within 6 hours or ≥ 6 apneic events requiring stimulation within 6 hours (4) emergent intubation by the clinical team for cardiovascular instability or surgery.
次要结局
- Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA(36 weeks PMA)
- Death or BPD at 36 weeks PMA(36 weeks PMA)
- Endotracheal intubation through 36 weeks PMA(36 weeks PMA)
- Postmenstrual age at last supplemental oxygen(36 weeks PMA)
- Postmenstrual age at last invasive ventilation(36 weeks PMA)
- Postmenstrual age at last positive pressure support(36 weeks PMA)
- Prematurity-related morbidities through 36 weeks PMA(36 weeks PMA)