Randomized Control Trial: Synchronized Non-Invasive Positive Pressure Ventilation (sNIPPV) With Neurally-Assisted Ventilatory Assist (NAVA) Versus NIPPV in Extremely Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The need for Mechanical Ventilation via ET tube ( MVET) at 7 days of life
研究概览
简要总结
Infants delivered weighing less than 1 kg at birth (ELBW) are at high risk for the development of bronchopulmonary dysplasia (BPD) and Ventilator-Induced Lung Injury (VILI), in part because of the need for mechanical ventilation utilizing an endotracheal tube (MVET). In spite of strategies to minimize the need for MVET, the incidence of BPD in ELBW infants continues to be 20-80%. The hypothesis is that synchronized NIPPV will decrease the need for MVET and reduce BPD in ELBW infants as compared to NIPPV.
详细描述
Hypothesis:
The hypothesis is that sNIPPV will decrease the need for MVET and reduce BPD in ELBW infants as compared to NIPPV.
Specific Aims:
The specific aims are to determine whether:
- sNIPPV results in a decreased need for MVET at 7days of life and 28 days of life in ELBW infants compared to NIPPV.
- sNIPPV reduces BPD in ELBW infants compared to NIPPV. Research design and methods: ELBW infants will be enrolled in this study at the RNICU at MFCH of WMC following informed written parental consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Babies born less than 1kg.
- •Babies born at 24-30 weeks gestation.
- •Babies who qualify for surfactant administration within 90mins of birth:
- •FiO2 > 0.4,
- •nCPAP > 6, with
- •Increased work of breathing as noted by grunting; and/or inter-, sub-, or supra-sternal retractions.
排除标准
- •Babies with Grade 3-4 IVH (may not be known prior to randomization).
- •Babies with congenital anomalies including neuromuscular disorder.
- •Babies who do not require intubation until 7 days of life.
结局指标
主要结局
The need for Mechanical Ventilation via ET tube ( MVET) at 7 days of life
时间窗: 7 days of life
Mechanical ventilation via Endotracheal tube
The need for Mechanical Ventilation via ET tube ( MVET) at 28 days of life
时间窗: 28 days of life
Mechanical Ventilation via Endotracheal tube
次要结局
- Incidence of BPD or need for supplemental O2 at 36 weeks corrected age(36 weeks corrected gestational age)