NCT01189162Unknown不适用
High Flow Nasal Cannula Versus Nasal Intermittent Mandatory Ventilation for Respiratory Distress Syndrome: a Randomized, Controlled, Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.
研究概览
简要总结
The investigators hypothesize that while the extremely low birthweight (ELBW) infants (<1000 g) may need NIMV for the treatment of RDS, larger infants or the smaller ones post extubation may enjoy the comfort benefits associated with HFNC while getting coparable respiratory support to NIMV.
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
- None
入排标准
- 年龄范围
- 1 Minute 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 24 to 34 and 6/7 weeks assessed by the obstetrical team from dating of last menstural period or ultrasound and weight >1000 g for the initial treatment of RDS or <35 weeks post extubation or for apnea of prematurity
- •Infants with RDS who will need NRS as initial therapy or after extubation and for apnea of prematurity,
- •written informed consent.
排除标准
- •Significant morbidity apart from RDS including: cardiac disease (not including patent ductus arteriosus [PDA]), congenital malformation, or if they had cardiovascular or respiratory instability because of sepsis, anemia or severe intraventricular hemorrhage (IVH),
- •Parents refuse consent.
- •Unavailability of suitable ventilator.
研究组 & 干预措施
NIMV- nasal respiratory support
Experimental
Infants with RDS will be treateg with nasal intermittent mandatory ventilation
干预措施: NIMV with SLE ventilator vs HFNC via Vapotherm (Device)
HFNC- nasal respiratory support with HFNC
Experimental
Infants with RDS will be treated with nasal respiratory support with high flow nasal canulla
干预措施: NIMV with SLE ventilator vs HFNC via Vapotherm (Device)
结局指标
主要结局
The percent of infants who will fail NRS and need endotracheal ventilation or will be switched to another mode of NRS.
时间窗: 1 year
次要结局
- Clinical features on both methods(1 year)
- % of infants with possible side effects on both methods(1 year)
- % of infants with neonatal morbidities on both methods(1 year)
研究者
研究点 (1)
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