Surfactant Clinical Trial
Official title:
A Multicenter Study of Pulmonary Surfactant(PS) Therapy in the Treatment of Neonatal Acute Respiratory Distress Syndrome(RDS) at High Altitude Area
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[1].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 [2].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.
Status | Completed |
Enrollment | 400 |
Est. completion date | December 31, 2017 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 12 Hours |
Eligibility |
Inclusion Criteria: - diagnosed with respiratory distress syndrome(RDS) Exclusion Criteria: - major congenital abnormalities |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | the first people hospital of Lasa, the first people hospital of Shigatse, the first people hospital of Tibet autonomous region, the people hospital of Ali, the people hospital of Changdu, the people hospital of Laqu, the people hospital of Linzhi, the people hospital of Shannan, the second people hospital of Lasa, the second people hospital of Tibet autonomous region, the Women and children hospital of Qinhai |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the intubation rate | the effect of PS treatment for NRDS | one week | |
Primary | the incidence of NRDS in different altitudes | different altitudes may result in different rate of NRDS | one week |
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