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Pulmonary Surfactant(PS) Therapy at High Altitude Area

A Multicenter Study of Pulmonary Surfactant(PS) Therapy in the Treatment of Neonatal Acute Respiratory Distress Syndrome(RDS) at High Altitude Area

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03440333
Enrollment
400
Registered
2018-02-22
Start date
2015-01-01
Completion date
2017-12-31
Last updated
2018-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NRDS, Surfactant

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\[1\].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.

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.

Interventions

DRUGsurfactant

Pulmonary surfactant was administrated if the baby was diagnosed with respiratory distress syndrome

Sponsors

the first people hospital of Tibet autonomous region
CollaboratorUNKNOWN
the second people hospital of Lasa
CollaboratorUNKNOWN
the first people hospital of Shigatse
CollaboratorUNKNOWN
the first people hospital of Lasa
CollaboratorUNKNOWN
the people hospital of Linzhi
CollaboratorUNKNOWN
the people hospital of Laqu
CollaboratorUNKNOWN
Shannan People's Hospital
CollaboratorOTHER
the people hospital of Changdu
CollaboratorUNKNOWN
the people hospital of Ali
CollaboratorUNKNOWN
the second people hospital of Tibet autonomous region
CollaboratorUNKNOWN
Women and Children Hospital of Qinghai Province
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 12 Hours

Inclusion criteria

* diagnosed with respiratory distress syndrome(RDS)

Exclusion criteria

* major congenital abnormalities

Design outcomes

Primary

MeasureTime frameDescription
the intubation rateone weekthe effect of PS treatment for NRDS
the incidence of NRDS in different altitudesone weekdifferent altitudes may result in different rate of NRDS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026