Surfactant Nebulization for the Early Aeration of the Preterm Lung: a Single Blinded, Parallel, Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- EIT: End-expiratory lung impedance (EELI)
研究概览
简要总结
Respiratory distress syndrome is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered via an endotracheal tube during mechanical ventilation. However, mechanical ventilation is considered an important risk factor for developing bronchopulmonary dysplasia.
Surfactant nebulisation during noninvasive ventilation may offer an alternative method for surfactant administration and has been shown to be promising in terms of physiological as well as clinical changes. In preterm infants with respiratory distress syndrome, the effect of intratracheally administered surfactant on lung function during invasive ventilation has been studied extensively. However, the effect of early postnatal surfactant nebulization remains unclear.
Therefore, the investigators plan to conduct a randomized controlled trial in order to investigate the effect of surfactant nebulization immediately after birth on early postnatal lung volume and short-term respiratory stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 3 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age at birth from 26 0/7 to 31 6/7 weeks
- •written informed consent
排除标准
- •severe congenital malformation adversely affecting surfactant nebulisation or life expectancy
- •a priori palliative care
- •genetically defined syndrome
研究组 & 干预措施
Surfactant nebulisation
The experimental group will receive a positive end-expiratory pressure (PEEP, +/- noninvasive positive pressure ventilation) and nebulised surfactant via a customised vibrating membrane nebuliser. Nebulisation will commence with the first application of a PEEP and will continue for a maximum of 30 minutes.
干预措施: Surfactant nebulisation (Drug)
结局指标
主要结局
EIT: End-expiratory lung impedance (EELI)
时间窗: Between birth and 30 minutes of life.
Change in EELI using electrical impedance tomography (arbitrary units per kilogram)
次要结局
- EIT: End-expiratory lung impedance (EELI)(At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age)
- Clinical: Number of episodes of desaturation and bradycardia(During the first 24 hours of life.)
- Clinical: Bronchopulmonary dysplasia (BPD)(At 36 weeks postmenstrual age.)
- Clinical: Intraventricular haemorrhage (IVH)(At 36 weeks postmenstrual age.)
- Clinical: Retinopathy of prematurity (ROP)(At 36 weeks postmenstrual age.)
- Clinical: Necrotizing enterocolitis (NEC)(At 36 weeks postmenstrual age.)
- EIT: Regional ventilation distribution(At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.)
- EIT: Tidal volumes(At 6, 12, and 24 hours of life and at 36 weeks postmenstrual age.)
- EIT: Association between EELI losses and SpO2/FiO2 ratio.(At 6, 12, and 24 hours of life.)
- EIT: Association between EELI losses and need/level of respiratory support.(At 6, 12, and 24 hours of life.)
- Physiological: Oxygen saturation (SpO2)(For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.)
- Physiological: Fraction of inspired oxygen(For the first 30 minutes after birth, and at 6, 12, and 24 hours of life.)
- Respiratory: PIP (peak inspiratory pressure)(At 6, 12, and 24 hours of life.)
- Respiratory: Respiratory rate(At 6, 12, and 24 hours of life.)
- Clinical: Length and type of noninvasive respiratory support(During the first 30 minutes of life.)
- Clinical: Total time on noninvasive and invasive respiratory support(Until 36 weeks postmenstrual age)
- Clinical: Frequency and duration of facemask repositioning(During the first 30 minutes after birth.)
- Clinical: Intubation(At 24 and 72 hours of life, at 7 days of life. Until 36 weeks postmenstrual age.)
- Clinical: Time to first intubation(From birth until 36 weeks postmenstrual age.)
- Clinical: Blood-culture positive sepsis(At 36 weeks postmenstrual age.)
- Physiological: Heart rate(For the first 30 minutes after birth, as well as at 6, 12, and 24 hours of life.)
- Physiological: SpO2/FiO2 ratio(At 6, 12, and 24 hours of life.)
- Respiratory: Positive end-expiratory pressure (PEEP)(During the first 30 minutes of life.)
- Respiratory: Tidal volume (Vt)(During the first 30 minutes of life.)
- Respiratory: PEEP (positive end-expiratory pressure)(At 6, 12, and 24 hours of life.)
- Physiological: Body temperature(In the delivery room.)
- Respiratory: Peak inspiratory pressure (PIP)(During the first 30 minutes of life.)