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临床试验/NCT03479450
NCT03479450Unknown不适用

Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年3月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
bronchopulmonary dysplasia(BPD)

研究概览

简要总结

The traditional concept believes that the etiology of neonatal respiratory distress syndrome (RDS) is immature development of lung,especially the surfactant synthesis system,and RDS is still one of the major causes of mortality and morbidity in newborns, especially premature infants.In recent years, using pulmonary surfactant replacement therapy (PS treatment) in the treatment of respiratory distress syndrome (RDS) is a major breakthrough in neonatal medicine.Combined with clinical practice and experience,and through Meta analysis of related randomized controlled trials (RCTs),it confirms that natural surfactant treatment can reduce mortality,the incidence of pulmonary air leaks (pneumothorax and interstitial lung emphysema),and the incidence of bronchopulmonary dysplasia (BPD) or 28-day-old mortality.For RDS in preterm infants whose gestation is <35 weeks ,surfactant replacement therapy is also more effective than in nearly term and full term infants.Therefore, in the analysis of cases of different gestational age groups,the investigators should focus on the study of premature infants cases.Due to less relevant research for using PS treatment to cure newborn RDS in high altitude area,this retrospective study conducts statistics and analysis of recently three-year cases in some hospital of high altitude area,to explore the treatment effect of the high altitude region and the impact of altitude on the treatment.

详细描述

in order to explore feasibility and efficacy for PS treatment of newborn RDS in high-altitude area ,and its efficacy at different altitudes, the investigators conduct a multi-center retrospective study of RDS cases in Qinghai and Tibet these two high-altitude area,and use RDS cases under the unique conditions to do statistics and analysis.

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
10 Minutes 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS

排除标准

  • parents' rejecting to join;major congenital abnormalities

结局指标

主要结局

bronchopulmonary dysplasia(BPD)

时间窗: before discharge or 36 weeks' gestational age

the incidence of BPD in infants with neonatal neonatal RDS

death

时间窗: before discharge or 36 weeks' gestational age

the incidence of BPD in infants with neonatal RDS

次要结局

  • necrotizing enterocolitis(NEC)(before discharge or 36 weeks' gestational age)
  • intraventriclular hemorrhage(IVH)(before discharge or 36 weeks' gestational age)

研究者

发起方
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ma Juan

Principal Investigator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

研究点 (1)

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