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Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study

NCT ID: NCT03479450

Last Updated: 2021-02-17

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

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-12-01

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.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.

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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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Surfactant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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surfactant

surfactant is given when neonatal respiratory distress syndrome is diagnosed

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Minutes

Maximum Eligible Age

1 Day

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

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

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ma Juan, MD

Role: CONTACT

[email protected]
13508300283

Chen Long, PhD,MD

Role: CONTACT

[email protected]
13883559467

Facility Contacts

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Juan Ma, physician

Role: primary

[email protected]
18680887330

Other Identifiers

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surfactant for NRDS

Identifier Type: -

Identifier Source: org_study_id

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