Pulmonary Surfactant(PS) Therapy at High Altitude Area

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT03440333

Collaborator

the first people hospital of Tibet autonomous region (Other), the second people hospital of Lasa (Other), the first people hospital of Shigatse (Other), the first people hospital of Lasa (Other), the people hospital of Linzhi (Other), the people hospital of Laqu (Other), Shannan People's Hospital (Other), the people hospital of Changdu (Other), the people hospital of Ali (Other), the second people hospital of Tibet autonomous region (Other), Women and Children Hospital of Qinghai Province (Other)

400

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NRDS Surfactant	Drug: surfactant

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.

Study Design

Study Type:

Observational

Actual Enrollment :

400 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Outcome Measures

Primary Outcome Measures

the intubation rate [one week]
the effect of PS treatment for NRDS
the incidence of NRDS in different altitudes [one week]
different altitudes may result in different rate of NRDS

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 12 Hours

Sexes Eligible for Study:

All

Inclusion Criteria:

diagnosed with respiratory distress syndrome(RDS)

Exclusion Criteria:

major congenital abnormalities

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ma Juan, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

ClinicalTrials.gov Identifier:

NCT03440333

Other Study ID Numbers:

pulmonary surfactant(PS)

First Posted:

Feb 22, 2018

Last Update Posted:

Feb 27, 2018

Last Verified:

Feb 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Surfactants

Study Results

No Results Posted as of Feb 27, 2018