Non-invasive Neurally Adjusted Ventilatory Assist Versus Nasal Intermittent Positive Pressure Ventilation for Preterm Infants After Extubation: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Treatment failure
研究概览
简要总结
Non-invasive respiratory support has been emerging in the management of respiratory distress syndrome (RDS) in preterm infants to minimise the risk of lung injury. Intermittent positive pressure ventilation (NIPPV) provides a method of augmenting continuous positive airway pressure (CPAP) by delivering ventilator breaths via nasal prongs.It may increase tidal volume, improve gas exchange and reduce work of breathing. However, NIPPV may associate with patient-ventilator asynchrony that can cause poor tolerance and risk of intubation. It may also in increased risk of pneumothorax and bowel perforation because of increase in intrathoracic pressure.
On the other hand, neurally adjusted ventilatory assist (NAVA) is a newer mode of ventilation, which has the potential to overcome these challenges. It uses the electrical activity of the diaphragm (EAdi) as a signal to synchronise the mechanical ventilatory breaths and deliver an inspiratory pressure based on this electrical activity. Comparing NI-NAVA and NIPPV in preterm infants, has shown that NI-NAVA improved the synchronization between patient and ventilator and decreased diaphragm work of breathing .
There is lack of data on the use of NI-NAVA in neonates post extubation in the literature. To date, no study has focused on short-term impacts. Therefore, it is important to evaluate the need of additional ventilatory support post extubation of NI-NAVA and NIPPV and also the risk of developing adverse outcomes.
Aim:
The aim is to compare NI-NAVA & NIPPV in terms of extubation failure in infants< 32 weeks gestation.
Hypothesis:
Investigators hypothesized that infants born prematurely < 32 weeks gestation who extubated to NI-NAVA have a lower risk of extubation failure and need of additional ventilatory support.
详细描述
Study Design: Randomised controlled trial
Study Setting: single center NICU level III, KFAFH tertiary care center , Jeddah Saudi Arabia
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
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born less than 32 weeks gestation with respiratory distress syndrome (RDS) and requiring endotracheal tube and mechanical ventilation.
- •Less than two weeks old
- •First extubation attempt
- •CRIB score 0-5
- •Written-informed parental consent for the study
排除标准
- •Major congenital malformations or respiratory abnormalities
- •Neuromuscular disease
- •phrenic nerve palsy
- •Intraventricular hemorrhage (IVH) grade III or IV
- •Absence of informed consent
- •Out born infants
结局指标
主要结局
Treatment failure
时间窗: 72 hours
1. Treatment failure during the first 72 hours post-extubation. 2. Reintubation (failure of extubation) within 72 hours' post extubation. Treatment failure is defined as: * Hypoxia (FiO 2 requirement \> 0.35) * Respiratory acidosis defined as pH \< 7.2 \& PCo2\> 60 mmHg * Major apnea requiring mask ventilation or \> 4 episodes/ hour. The protocol will discontinue according to treatment failure criteria as mentioned above. Rescue treatment with NIPPV will be allowed and will be considered as treatment failure
次要结局
- Intraventricular haemorrhage IVH (grades III & IV)(7 days after extubation)
- Death prior to discharge(90 days from birth)
- Pneumothorax(7 days after extubation)
- Bronchopulmonary dysplasia (BPD)(36 weeks' postmenstrual age)
- Necrotizing enterocolitis(7 days after extubation)
- Gastrointestinal perforation(7 days after extubation)
- Nosocomial sepsis(7 days after extubation)
- Retinopathy of prematurity (ROP)(40 weeks corrected postnatal age)
- Duration of hospitalisation or Length of stay (in days)(From admission to first discharge from hospital, assessed up to 6 months)
研究者
Dr. Raniah Aljeaid
Neonatal Fellow
King Fahad Armed Forces Hospital