Pulmonary Surfactant(PS) Therapy at High Altitude Area

Surfactant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440333
• Other study ID #: pulmonary surfactant(PS)
• Status: Completed
• Phase: N/A
• First received: February 3, 2018
• Last updated: February 26, 2018
• Start date: January 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

Inclusion Criteria:

• diagnosed with respiratory distress syndrome(RDS)

Exclusion Criteria:

• major congenital abnormalities

Related Conditions & MeSH terms

• NRDS
• Respiratory Distress Syndrome, Adult
• Surfactant

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor

Collaborator

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

the first people hospital of Lasa, the first people hospital of Shigatse, the first people hospital of Tibet autonomous region, the people hospital of Ali, the people hospital of Changdu, the people hospital of Laqu, the people hospital of Linzhi, the people hospital of Shannan, the second people hospital of Lasa, the second people hospital of Tibet autonomous region, the Women and children hospital of Qinhai

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the intubation rate	the effect of PS treatment for NRDS	one week
Primary	the incidence of NRDS in different altitudes	different altitudes may result in different rate of NRDS	one week