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Clinical Trials/NCT03479450
NCT03479450
Unknown
Not Applicable

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 site in 1 country200 target enrollmentMarch 1, 2020
ConditionsSurfactant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surfactant
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrollment
200
Locations
1
Primary Endpoint
bronchopulmonary dysplasia(BPD)
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2020
End Date
December 1, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Responsible Party
Principal Investigator
Principal Investigator

Ma Juan

Principal Investigator

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • parents' rejecting to join;major congenital abnormalities

Outcomes

Primary Outcomes

bronchopulmonary dysplasia(BPD)

Time Frame: before discharge or 36 weeks' gestational age

the incidence of BPD in infants with neonatal neonatal RDS

death

Time Frame: before discharge or 36 weeks' gestational age

the incidence of BPD in infants with neonatal RDS

Secondary Outcomes

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

Study Sites (1)

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