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临床试验/NCT02842190
NCT02842190Unknown不适用

Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight

Zekai Tahir Burak Women's Health Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年1月15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
140
试验地点
1
主要终点
Rate of extubation failure

研究概览

简要总结

Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.

Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.

详细描述

In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.

Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.

Extubation failure was defined as: development of respiratory acidosis (blood gases with pH < 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 < 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.

Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.

The primary end-point, rate of extubation failure within 96 hours following first extubation, 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
Supportive Care
盲法
None

入排标准

年龄范围
1 Day 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Mechanically ventilated preterm infants with birthweight ≤1250 g

排除标准

  • Infants with major congenital malformations, neuromuscular disease and lack of parental consent

研究组 & 干预措施

BIPAP

No Intervention

BIPAP after ekstubation

NIPPV

Active Comparator

NIPPV after ekstubation

干预措施: NIPPV (Device)

结局指标

主要结局

Rate of extubation failure

时间窗: within 96 hours

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
Principal Investigator
主要研究者

nilüfer okur

NEONATOLOGY

Zekai Tahir Burak Women's Health Research and Education Hospital

研究点 (1)

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