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临床试验/NCT02030652
NCT02030652Unknown不适用

Impact of Synchronized Nasal Intermittent Positive Pressure Ventilation Using Non Invasive Neurally Adjusted Ventilatory Assist (NAVA) in Preterm Infants With Respiratory Distress

Hospital Israelita Albert Einstein2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
56
试验地点
2
主要终点
Need for endotracheal intubation

研究概览

简要总结

The nasal CPAP (continuous positive airway pressure), is a technique of noninvasive ventilation commonly used in neonatal intensive care units, and has recently been used in association with nasal intermittent mandatory ventilation (NIPPV - intermittent Nasal Positive Pressure Ventilation), which consists of the application of respiratory positive pressure cycles during the application of nasal CPAP, resulting in high pharyngeal pressures. The NIPPV has advantages over traditional CPAP, including the prevention of atelectasis, improved respiratory mechanics and decreased work of breathing in premature infants. A refinement of this technique is the use of positive pressure breaths associated with nasal CPAP synchronously in relation to the newborn's inspiratory effort (SNIPPV - Synchronized Nasal Positive Pressure Ventilation).

Synchronization allows that the cycles of inspiratory positive pressure provided by the ventilator coincide with the inspiratory effort, increasing the system efficacy. The Neurally Adjusted Ventilatory Assist (NAVA) is a mode of partial ventilatory support based on the use of electrical activity of the diaphragm (Edi) to control the mechanical ventilator. The ventilatory assistance starts according to respiratory needs of the patient, its use in very low birth weight infants showed an improvement in patient-ventilator interaction, even in the presence of leak around the endotracheal tube. This prospective randomized, clinical trial aims to evaluate, in preterm infants with gestational age lower than 34 weeks with respiratory failure treated with noninvasive ventilatory support, the impact of SNIPPV with neural adjustment (NAVA) on success ventilation and the need for endotracheal intubation when compared to treatment with traditional CPAP.

详细描述

Type and location of the study A prospective , randomized , open label clinical study will be conducted at the Albert Einstein Jewish Hospital Neonatal ICU, after approval by the Ethics Committee and the Research Institute of Education and Research. To participate in the study the parents or legal guardians must complete and sign the Statement of Consent.

Randomization and formation of study groups Two study groups will be formed according to the type of non- invasive ventilatory support: SNIPPV Group (synchronized nasal intermittent positive pressure) and CPAP group (continuous positive airway pressure). The formation of study groups will be by randomization through opaque envelopes containing in its interior the type of treatment to be used. The envelopes will be opened at the initiation of treatment.

Inclusion Criteria Will be included in study preterm infants with respiratory failure and indication of noninvasive ventilatory support, characterized by clinical evidence of respiratory failure requiring use of oxygen greater than or equal to a FiO2 0.25.

Exclusion Criteria Will be excluded from the study infants that parents did not agree on participation; diagnosed with major congenital anomalies; with necessity of chest drainage; diagnosis of intracranial hemorrhage grades III and IV according to the criteria of Papile et al; persistence ductus arteriosus with hemodynamic consequences and diagnosis of severe perinatal asphyxia - defined as less than 6 APGAR with 5 minutes of life.

Definition of the primary variable and secondary variables:

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
23 Weeks 至 36 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Will be included in study preterm infants with respiratory failure and indication of noninvasive ventilatory support, characterized by clinical evidence of respiratory failure requiring use of oxygen greater than or equal to a FiO2 0.25.

排除标准

  • Will be excluded from the study infants that parents did not agree on participation; diagnosed with major congenital anomalies; with necessity of chest drainage; diagnosis of intracranial hemorrhage grades III and IV according to the criteria of Papile et al; persistence ductus arteriosus with hemodynamic consequences and diagnosis of severe perinatal asphyxia - defined as less than 6 APGAR with 5 minutes of life.

研究组 & 干预措施

SNIPPV Group

Experimental

Synchronized nasal intermittent positive pressure using NAVA ( Intermittent nasal positive pressure positive ventilation.)

干预措施: Intermittent nasal positive pressure positive ventilation. (Procedure)

CPAP Group

Active Comparator

Nasal CPAP group without intermittent ventilation.

干预措施: CPAP (Procedure)

结局指标

主要结局

Need for endotracheal intubation

时间窗: 7 days

Necessity of intubation and mechanical ventilation until the end of the first week of life.

次要结局

  • Total time of nCPAP(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celso Rebello MD

MD PhD

Hospital Israelita Albert Einstein

研究点 (2)

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