Pregnancy Risk Factors Promote Conversion From Neonatal Respiratory Distress Syndrome(NRDS) to Acute Respiratory Distress Syndrome(ARDS) : a Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
研究概览
简要总结
Acute respiratory distress syndrome in neonates has been defined in 2015. Earlier identification and successful intervention into the potential pregnancy associated risk factors for the conversion from NRDS to ARDS is one of the most important components of ARDS prevention.
详细描述
Pregnancy risk factors (PRF), such as intrahepatic cholestasis during pregnancy(ICP), hypertensive disorder complicating pregnancy(HDCP) and gestational diabetes mellitus(GDM), are related to NRDS, ARDS and subsequent death. Meantime, it has also been proven that the prevention of PRF reduces the risk of NRDS and ARDS. However, few study reported the relations between PRF and the conversion from NRDS to ARDS, and it also remains unknown whether treating PRF can reduce the progression from NRDS to ARDS.
We have found that PRF were related to the increase and deterioration of NRDS in a Chinese cohort. The aims of the present study were: 1). to report the effects of PRF on the conversion from NRDS to ARDS. 2). to clarify whether PRF treatment could prevention from conversion from NRDS to ARDS in a Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Minutes 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The gestational age was less than 37 weeks;
- •These neonates were diagnosed with NRDS; The diagnosis of NRDS was based on clinical manifestations and chest X-ray findings. The clinical signs and symptoms of NRDS were respiratory distress, tachypnea, nasal flaring, groan, and cyanosis after birth. The typical X-ray picture of RDS showed a grain shadow, air bronchogram or white lung.
- •informed parental consent has been obtained
排除标准
- •parents' decision not to participate;
- •major congenital anomalies;
- •died or left the neonatal intensive care unit(NICU) within 24 hour.
结局指标
主要结局
clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
时间窗: within 28 days
clarify whether PRF treatment could prevention from conversion from NRDS to ARDS
the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
时间窗: within 28 days
the effects of Pregnancy risk factors (PRF) on the conversion from NRDS to ARDS
次要结局
未报告次要终点
研究者
Ma Juan
Principal Investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University