Inhaled Salbutamol in Elective Caesarean Section
试验速览
- 阶段
- 4 期
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth
研究概览
简要总结
The lungs of the fetus are filled with fluid and it is essential that fetal lung fluid is cleared at birth. This process is mediated through the activation of airway epithelial sodium channels (ENaC). In animals, ENaC is considered crucial for postnatal pulmonary adaptation. In humans, postnatal ENaC expression is dependent on gestational age and its activity, measured as nasal potential difference, correlates with lung compliance. Therefore, in the human newborn infant ENaC may be important for physiologic postnatal adaptation. The activity of ENaC is increased by beta-agonists, such as salbutamol. We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS).
详细描述
We hypothesize that low pulmonary expression or activity of ENaC in the perinatal period causes delayed clearance of lung fluid and thereby contributes to the risk for development of transient tachypnea of the newborn (TTN) in term infants born by Caesarean section (CS). The aim of this study is to evaluate whether the respiratory status, measured by a transthoracic ultrasound method and lung compliance, of newborns infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age. 62 infants will be included and randomized to receive salbutamol or placebo-inhalations in a double-blind manner.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy singleton pregnancy
- •Cesarean section at 37 + 0 to 41 + 6 gestational weeks
排除标准
- •clinically significant congenital malformations
- •birth weight < 2000 grams
- •intubation
- •200 bp for more than 5 min
- •relevant medication of the mother, e.g. albetol, beta-agonists (e.g. salbutamol, salmeterol), corticosteroids
- •the suspicion of/confirmed pneumothorax or infection
研究组 & 干预措施
Placebo
Placebo is administered once, at 30-60 minutes of age
干预措施: Placebo (Drug)
Intervention
Salbutamol 0,4 mg inhalation, given once at 30-60 minutes of age
干预措施: salbutamol (Drug)
结局指标
主要结局
To evaluate whether lung ultrasound at 30-60 minutes of birth is improved at 3-6 hours of birth
时间窗: 6 hours
To evaluate whether the respiratory status measured by a transthoracic ultrasound method of newborn infants born by CS can be improved by inhaled salbutamol at 30-60 minutes of age.
次要结局
- To evaluate whether lung compliance measured at 3-6 hours is improved by inhaled salbutamol at 30-60 minutes of age(6 hours)
- Decrease in respiratory rate at 3-6 hours of age(6 hours)
- To see whether there is a correlation between airway ENaC expression measured at 30-60 minutes of age and consequent lung fluid content at 3-6 hours of age(6 hours)
- Whether cord blood cortisol concentrations correlate with expression of ENaC and further, with decrease in lung fluid content at 3-6 hours of age(6 hours of age)
研究者
Sture Andersson
Professor in Neonatology
Helsinki University Central Hospital