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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03479450
Enrollment
200
Registered
2018-03-27
Start date
2020-03-01
Completion date
2022-12-01
Last updated
2021-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surfactant

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.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.

Detailed 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.

Interventions

DRUGsurfactant

surfactant is given when neonatal respiratory distress syndrome is diagnosed

Sponsors

the first people hospital of Tibet autonomous region
CollaboratorUNKNOWN
the second people hospital of Lasa
CollaboratorUNKNOWN
the first people hospital of Shigatse
CollaboratorUNKNOWN
the first people hospital of Lasa
CollaboratorUNKNOWN
the people hospital of Linzhi
CollaboratorUNKNOWN
the people hospital of Laqu
CollaboratorUNKNOWN
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Minutes to 1 Days

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

Design outcomes

Primary

MeasureTime frameDescription
bronchopulmonary dysplasia(BPD)before discharge or 36 weeks' gestational agethe incidence of BPD in infants with neonatal neonatal RDS
deathbefore discharge or 36 weeks' gestational agethe incidence of BPD in infants with neonatal RDS

Secondary

MeasureTime frameDescription
intraventriclular hemorrhage(IVH)before discharge or 36 weeks' gestational agethe incidence of IVH in infants with neonatal RDS
necrotizing enterocolitis(NEC)before discharge or 36 weeks' gestational agethe incidence of NEC in infants with neonatal RDS

Countries

China

Contacts

Primary ContactMa Juan, MD
petshi530@vip.163.com13508300283
Backup ContactChen Long, PhD,MD
476679422@qq.com13883559467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026