Pulmonary Surfactant(PS) Therapy at High Altitude Area

NCT03440333 | Completed DMC

• 1 other identifier: pulmonary surfactant(PS)
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

NRDS; Surfactant

Outcome Measures

Primary Outcomes (2)

• the intubation rate

  the effect of PS treatment for NRDS

  one week

• the incidence of NRDS in different altitudes

  different altitudes may result in different rate of NRDS

  one week

Interventions

surfactant DRUG

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

Eligibility Criteria

• Age: 1 Minute - 12 Hours
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

the preterm infants less than 37 weeks were included in the study

You may qualify if:

• diagnosed with respiratory distress syndrome(RDS)

You may not qualify if:

• major congenital abnormalities

Sponsors & Collaborators

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

MeSH Terms

Interventions

Surface-Active Agents

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: February 3, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02