跳至主要内容
临床试验/NCT02543125
NCT02543125Unknown不适用

Nasal High Frequency Oscillatory Versus Nasal Intermittent Positive Pressure Ventilation in Neonate After Extubation

Gao WeiWei0 个研究点目标入组 75 人开始时间: 2016年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
75
主要终点
intubation rate

研究概览

简要总结

To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in preterms with respiratory disease syndrome(RDS) after extubation.

详细描述

To very low birth weight infant(VLBW) with respiratory disease syndrome(RDS) who need mechanical ventilation,early extubation may have more benefits.Early extubation may decrease the ventilation-associated pneumonia(VAP),sepsis and decrease the incidence of severity bronchopulmonary dysplasia(BPD).But often fail attempts at extubation because of apnea,atelectasis,hypercapnia,hypoventilation or other illnesses.

High frequency oscillatory ventilation is benefit to lung.Initial ventilation with HFOV in preterm with RDS may reduce the incidence of BPD and improve the neurodevelopment.Compared HFOV with conventional ventilation in preterm infants showed that HFOV had superior lung function when 11 to 14 years age.Whether nasal high frequency oscillatory ventilation(NHFOV) also have those advantages in non-invasive mode? Null D M et al do a experiment on preterm lambs,the result suggest that NHFOV may promotes alveolarization.But there was no clinical trials to prove.

The nasal intermittent positive pressure ventilation (NIPPV) group fail definition:1、 Fraction of inspired oxygen (FiO2)>40%、MAP>12 centimeter water column (cm H2O),but arterial oxygen saturation (SaO2)<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg)or partial pressure of arterial oxygen (PaO2)<45 millimeter of mercury(mmHg).4、severe apnea( definition:>6 episodes requiring stimulation in 6 hours or requiring >1 episodes of positive-pressure ventilation) 5.potential of hydrogen (PH)<7.2 The

The NHFOV group fail definition:1、FiO2>40%、MAP>14 mbar,but SaO2<90%.2、significant abdominal distension.3、PaCO2>60millimeter of mercury(mmHg) or PaO2<45millimeter of mercury(mmHg).4、severe apnea 5.PH<7.2.

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 Hour 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • birth weight>1000g
  • gestational age >28 weeks
  • have respiratory distress syndrome and need invasive ventilation

排除标准

  • birth wight<1000g
  • gestational age <28 weeks
  • infants wiht abnormalities of upper and lower airways
  • infants have contraindications of non-invasive ventilation -

结局指标

主要结局

intubation rate

时间窗: 72 hours

endotracheal intubation rate assessed within 72 hours after extubation

次要结局

  • significant apnea(7 days)
  • air leaks(3 months)
  • Bronchopulmonary dysplasia(3 months)
  • necrotizing enterocolitis(3 months)

研究者

发起方
Gao WeiWei
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gao WeiWei

professor

Guangdong Women and Children Hospital

相似试验

Nasal High Frequency Oscillatory Versus Nasal... | 临床试验