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临床试验/NCT03289936
NCT03289936已完成不适用

Short Term Effects of Synchronized vs. Non-synchronized NIPPV in Preterm Infants: Study Protocol for an Unmasked Randomized Crossover Trial.

University of Turin, Italy3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年11月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
3
主要终点
Frequency of episodes of desaturation

研究概览

简要总结

Comparing the cardio-respiratory adaptation and differences to non invasive ventilation techniques, nasal intermittent positive pressure ventilation (NIPPV) non synchronized vs synchronized (SNIPPV) in preterm newborns (gestational age at birth < 32 weeks) at their first approach to non invasive ventilation as first intention (soon after birth) or after extubation.

详细描述

Respiratory problems are one of the major issues to deal with in preterm newborns.

Because of the immaturity of respiratory mechanisms and structures, the use of supporting devices is often necessary. These include both conventional mechanical ventilation (MV) techniques, which require the use of an endotracheal tube, as well as non-invasive ventilation (NIV) techniques that use softer ventilator-patient interfaces. Increasing attention is payed to the latter ones as less aggressive and associated with better outcomes both in terms of mortality and short and long-term complications, such as bronchopulmonary dysplasia (BPD).

Nasal intermittent positive pressure ventilation (NIPPV) is a NIV technique in which newborn airways are kept open between two pressure levels: peak inspiratory pressure (PIP) and positive end expiratory pressure (PEEP). The frequency and duration of each phase are defined by setting the inspiratory and expiratory times or the ventilation rate.

This technique has already shown its superiority in terms of reduced duration of MV, reduced necessity of intubation, decreased failure of extubating and reduced prevalence of BPD if compared with non-invasive techniques based on continuous pressure support, such as continuous positive airway pressure (CPAP). Recent meta-analyses of studies where NIPPV has been used as an alternative to CPAP following extubation show that it reduces need for re-ventilation and air leaks but without any reduction in BPD: there is insufficient evidence to recommend NIPPV as primary mode of respiratory support in the delivery room.

It should be specified that the ventilation rate on NIPPV does not reflect the real respiratory rate (RR) of the newborn, as the ventilator supplies the PIP regardless of newborn respiratory efforts. To reproduce a more physiological and gentle ventilation new devices able to detect newborn respiratory efforts and consequently supply a PIP have been developed to synchronize the ventilation rate with RR of the newborn.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Gestational age at birth <32 weeks
  • First approach to NIV ventilation (primary or after extubation)
  • Parent's informed consent

排除标准

  • Neurological (including IVH > 2° grade) or surgical diseases
  • Sepsis (clinical or laboratory confirmed)
  • Chromosomal or genetic abnormalities
  • Major malformations and congenital anomalies
  • Cardiac problems (including hemodynamically significant PDA)
  • Contraindication to NIV (i.e. nasal trauma and gastrointestinal surgery within the previous 7 days).

研究组 & 干预措施

Start ventilation with NIPPV

Experimental

Alternatively vented with NIPPV and SNIPPV

干预措施: SNIPPV (Device)

Start ventilation with SNIPPV

Experimental

Alternatively vented with SNIPPV and NIPPV

干预措施: NIPPV (Device)

Start ventilation with SNIPPV

Experimental

Alternatively vented with SNIPPV and NIPPV

干预措施: SNIPPV (Device)

Start ventilation with NIPPV

Experimental

Alternatively vented with NIPPV and SNIPPV

干预措施: NIPPV (Device)

结局指标

主要结局

Frequency of episodes of desaturation

时间窗: 3 hours of NIPPV vs 3 hours SNIPPV

Desaturation is defined as a blood oxygen saturation below 80% for 4 sec. or more

次要结局

  • Synchronization index(3 hours of NIPPV vs 3 hours SNIPPV)
  • Number of cardiorespiratory events(3 hours of NIPPV vs 3 hours SNIPPV)
  • Patient-ventilator concordance(3 hours of NIPPV vs 3 hours SNIPPV)
  • O2 needing during SNIPPV vs NIPPV monitoring to maintain SatO2 TC between 90 and 94%(3 hours of NIPPV vs 3 hours SNIPPV)
  • Newborn pain score evaluation during SNIPPV vs NIPPV monitoring.(3 hours of NIPPV vs 3 hours SNIPPV)
  • Thoracoabdominal asynchrony(3 hours of NIPPV vs 3 hours SNIPPV)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Cresi, MD, PhD

MD, PhD

University of Turin, Italy

研究点 (3)

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