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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03479450
Other study ID # surfactant for NRDS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01265589 - Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome Phase 3
Completed NCT03273764 - Clinical RD (Respiratory Distress) Score for Objective Decision Making for Surfactant Therapy N/A
Completed NCT03440333 - Pulmonary Surfactant(PS) Therapy at High Altitude Area N/A
Recruiting NCT03217162 - Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS) N/A