Clinical trial NCT03479450: Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
Official title: Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surfactant
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: the first people hospital of Tibet autonomous region
name: the second people hospital of Lasa
name: the first people hospital of Shigatse
name: the first people hospital of Lasa
name: the people hospital of Linzhi
name: the people hospital of Laqu
First posted: 2018-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 1
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.

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.

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

Primary outcomes:
measure: bronchopulmonary dysplasia(BPD)
timeFrame: before discharge or 36 weeks' gestational age
measure: death
timeFrame: before discharge or 36 weeks' gestational age
Secondary outcomes:
measure: intraventriclular hemorrhage(IVH)
timeFrame: before discharge or 36 weeks' gestational age
measure: necrotizing enterocolitis(NEC)
timeFrame: before discharge or 36 weeks' gestational age
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
References: