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临床试验/NCT03400670
NCT03400670Unknown不适用

Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome With Gestational Age of 26-30 Weeks

Zekai Tahir Burak Women's Health Research and Education Hospital2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2017年1月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
2
主要终点
noninvasive ventilation failure

研究概览

简要总结

is to compare introduction of two different NCPAP methods in terms of mechanical ventilation (MV) need (non-invasive respiratory support failure) and surfactant need within the first 72 hours of life in preterm infants with Respiratory Distress Syndrome (RDS) at 26-30 weeks of gestation.

详细描述

Study Design NCPAP support was provided with continuous positive airway pressure, which was generated by a neonatal ventilator (SLE; Infant Flow System, Viasys Corp., USA) and infant flow-driver device (SLE; The respiratory parameter settings were a PEEP of 5-8 cmH2O. CPAP was stopped when PEEP 5 cmH2O and infants showed no signs of RDS with FiO2 <0.30.

Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.

Non-invasive respiratory support failure is set as follows:

  • FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
  • Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
  • Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
  • Severe respiratory distress,
  • Pulmonary haemorrhage and cardiopulmonary arrest.

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 2 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infant with gestational age of 26 weeks 0 days and 29 weeks 6 days with RDS signs will be included

排除标准

  • Major congenital anomalies
  • Presence of cardiovascular instability
  • Intubation at admission to the NICU
  • Consent not provided or refused

研究组 & 干预措施

Ventilator NCPAP

Active Comparator

neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O

干预措施: ventilator NCPAP (Device)

Infant Flow-driver NCPAP

Active Comparator

infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow

干预措施: ventilator NCPAP (Device)

结局指标

主要结局

noninvasive ventilation failure

时间窗: 72 hours

need for mechanical ventilation in the first 72 hours of life

次要结局

未报告次要终点

研究者

发起方
Zekai Tahir Burak Women's Health Research and Education Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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