Pulmonary Surfactant(PS) Therapy at High Altitude Area

NCT ID: NCT03440333

Last Updated: 2018-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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NRDS Surfactant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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surfactant

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosed with respiratory distress syndrome(RDS)

Exclusion Criteria

* major congenital abnormalities
Minimum Eligible Age

1 Minute

Maximum Eligible Age

12 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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the first people hospital of Tibet autonomous region

UNKNOWN

Sponsor Role collaborator

the second people hospital of Lasa

UNKNOWN

Sponsor Role collaborator

the first people hospital of Shigatse

UNKNOWN

Sponsor Role collaborator

the first people hospital of Lasa

UNKNOWN

Sponsor Role collaborator

the people hospital of Linzhi

UNKNOWN

Sponsor Role collaborator

the people hospital of Laqu

UNKNOWN

Sponsor Role collaborator

Shannan People's Hospital

OTHER

Sponsor Role collaborator

the people hospital of Changdu

UNKNOWN

Sponsor Role collaborator

the people hospital of Ali

UNKNOWN

Sponsor Role collaborator

the second people hospital of Tibet autonomous region

UNKNOWN

Sponsor Role collaborator

Women and Children Hospital of Qinghai Province

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Ma Juan

director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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pulmonary surfactant(PS)

Identifier Type: -

Identifier Source: org_study_id

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