Comparison of Efficacy of Less Invasive Surfactant Treatment Under Nasal CPAP and Nasal IPPV in Premature Babies: CURLISPAP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Treatment failure within 72 hours after randomization 72 hours after randomization
研究概览
简要总结
Non invasive ventilation is important in the care of preterm infants with respiratory failure, and surfactant treatment can be use with non invasive ventilation. However, there is no consensus on the best non-invasive ventilation mode for surfactant treatment in preterm infants.
Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus nasal continuous positive airway pressure (CPAP) in preterm infants ≤ 29 week gestational age.
详细描述
This CURLISPAP study was a multicenter, randomized controlled study at six level III neonatal intensive care units (NICUs) in Turkey. The protocol was approved by the ethics committee of each participating centre and Turkish Ministry of Health, Turkish Medicines and Medical Devices Agency.
Non invasive ventilated preterm infants with respiratory distress syndrome and gestational age from 241/7 weeks to 296/7 weeks were enrolled within 6 h of birth. Infants with major congenital malformations, need of mechanical ventiation, need of entubation in delivery room and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and CPAP group). The short binasal prongs will use as interface. For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.30 target SpO2 90-94%.
For all groups Surfactant by "LISA" technique and with special catheter (LISAcath, Chiesi Pharmaceutics) of surfactant (Curosurf, Chiesi Pharmaceutics) 200 mg/kg.
The primary end-point, need of mechanical ventilation within 72 hours following surfactant treatment, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.
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
- 24 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age 24 -29 week
- •Clinical and radiological diagnosis of RDS
- •Born in a hospital with a study center
- •Spontaneous breathing
- •Within the first 6 hours
- •Non-invasive ventilation and FiO2 requirement >0.30
- •Parental concent
排除标准
- •Major congenital malformations
- •Need of mechanical ventiation
- •Need of entubation in delivery room
- •Air weak syndrome
- •No parental concent
研究组 & 干预措施
NCPAP
Ventilator-derived NCPAP will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-94.
Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O.
干预措施: NCPAP (Other)
NCPAP
Ventilator-derived NCPAP will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NCPAP settings are: PEEP:6 cmH2O and FiO2: adjusted to keep preductal sPO2 between %90-94.
Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O.
干预措施: NIPPV (Other)
NIPPV
Ventilator-derived NIPPV will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NIPPV settings are: PEEP:6 cmH2O, PIP: 15 cmH2O, Rate: 30-40/ bpm and FiO2: adjusted to keep preductal sPO2 between %90-94.
Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O.
干预措施: NCPAP (Other)
NIPPV
Ventilator-derived NIPPV will be administered using binasal prongs. Standard Devices or infant flow-driver device. Initial NIPPV settings are: PEEP:6 cmH2O, PIP: 15 cmH2O, Rate: 30-40/ bpm and FiO2: adjusted to keep preductal sPO2 between %90-94.
Failure is defined as FiO2 requirement of >%50, capillary blood gas obtained at the 4th hour of therapy showing pH<7.20 or pCO2>60 cmH2O.
干预措施: NIPPV (Other)
结局指标
主要结局
Treatment failure within 72 hours after randomization 72 hours after randomization
时间窗: within 72 hours after randomization
Need for invasive mechanical ventilation
次要结局
- Rate of bronchopulmonary dysplasia(36 weeks of postmenstrual age ])
研究者
Hilal Ozkan
Professor
Uludag University