Establishment and Evaluation of Prenatal Prevention and Treatment Strategy for Neonatal Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
研究概览
简要总结
- A predictive model for NARDS was established based on perinatal risk factors. Multivariate Logistic regression analysis was used to screen the independent prenatal risk factors for NARDS. A Logistic regression model was constructed using the above independent risk factors and quantified in a nomogram to construct a visualization model for prenatal prediction of NARDS.
- The role of ACS in the prevention and treatment of ARDS in near-term/full-term infants.
For neonates with a probability greater than 80% in the prediction model of ARDS, at least one ACS was given before the termination of pregnancy. The GC level of cord blood (taken at birth) and the mRNA levels of α-ENaC, Na-K-atpase and SGK1 in nasal epithelium were measured within 2 hours and 1 day after birth in the ACS intervention group and the control group. The occurrence and severity of pulmonary edema, the occurrence and severity of ARDS, and the mortality rate of NARDS were evaluated by lung ultrasound. The indexes of the two groups were compared horizontally and longitudinally.
详细描述
Based on the proposed scientific hypothesis, the project team intends to achieve the following research objectives through scientific experiments:
To explore the role of ACS in promoting fetal lung maturation from the perspective of lung fluid clearance through the traditional concept that ACS promotes fetal lung maturation mainly by inducing PS, so as to further expand the object and scope of ACS application.
The prenatal prediction model of ARDS was established by using perinatal risk factors, and the predictive value was visualized.
To explore the clinical value and mechanism of ACS in pregnant women at high risk of NARDS, and to open up new ideas for the prevention and treatment of NARDS from the perspective of promoting lung fluid clearance; The early prevention and treatment strategy of NARDS was established by combining the "prenatal prediction model +ACS", and its effect was evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The pregnant women with a probability greater than 80% in the prediction model of neonatal acute respiratory distress syndrome and agreed to ACS intervention.
- •Obtaining patient consent.
排除标准
- •the pregnant women with a probability of less than 80% in the neonatal acute respiratory distress syndrome prediction model.
- •The patient refuses.
研究组 & 干预措施
the experimental group
For pregnant women with a probability greater than 80% in the prediction model of NARDS, those who agreed to ACS intervention were included in the experimental group
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium
时间窗: Day 0 after birth
The mRNA levels of α-ENaC, Na-K-atpase, and SGK1 in nasal epithelium will be compared between the two groups
The glucocorticoid level in cord blood
时间窗: Day 0 after birth
The glucocorticoid levels of cord blood will be compared between the two groups
The incidence and severity of pulmonary edema
时间窗: 1 year
The incidence and severity of pulmonary edema will be compared between the two groups
The incidence and severity of neonatal acute respiratory distress syndrome
时间窗: 1 year
The incidence and severity of neonatal acute respiratory distress syndrome will be compared between the two groups
The mortality of NARDS
时间窗: 1 year
The mortality rate of NARDS will be compared between the two groups
次要结局
未报告次要终点