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

Surfactant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479450
• Other study ID #: surfactant for NRDS
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: February 2021
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13508300283
• Email: petshi530[@]vip.163.com
• 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.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.

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: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Gender: All
• Age group: N/A to 1 Day

Eligibility

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

Related Conditions & MeSH terms

• Hyaline Membrane Disease
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Surfactant

Intervention

Drug:
• surfactant
surfactant is given when neonatal respiratory distress syndrome is diagnosed

Locations

Country	Name	City	State
China	Department of Pediatrics, Daping Hospital, Third Military Medical University	Chongqing	Chongqing

Sponsors (7)

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 Laqu, the people hospital of Linzhi, the second people hospital of Lasa

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bronchopulmonary dysplasia(BPD)	the incidence of BPD in infants with neonatal neonatal RDS	before discharge or 36 weeks' gestational age
Primary	death	the incidence of BPD in infants with neonatal RDS	before discharge or 36 weeks' gestational age
Secondary	intraventriclular hemorrhage(IVH)	the incidence of IVH in infants with neonatal RDS	before discharge or 36 weeks' gestational age
Secondary	necrotizing enterocolitis(NEC)	the incidence of NEC in infants with neonatal RDS	before discharge or 36 weeks' gestational age