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

NCT03479450 | Unknown DMC

• 1 other identifier: surfactant for NRDS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Surfactant

Outcome Measures

Primary Outcomes (2)

• bronchopulmonary dysplasia(BPD)

  the incidence of BPD in infants with neonatal neonatal RDS

  before discharge or 36 weeks' gestational age

• death

  the incidence of BPD in infants with neonatal RDS

  before discharge or 36 weeks' gestational age

Secondary Outcomes (2)

• intraventriclular hemorrhage(IVH)

  before discharge or 36 weeks' gestational age

• necrotizing enterocolitis(NEC)

  before discharge or 36 weeks' gestational age

Interventions

surfactant DRUG

surfactant is given when neonatal respiratory distress syndrome is diagnosed

Eligibility Criteria

• Age: 10 Minutes - 1 Day
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.

You may qualify if:

• the preterm infants less than 37 weeks were included in the study;diagnosed with NRDS

You may not qualify if:

• parents' rejecting to join;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

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Interventions

Surface-Active Agents

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Central Study Contacts

Ma Juan, MD

CONTACT

13508300283; petshi530@vip.163.com

Chen Long, PhD,MD

CONTACT

13883559467; 476679422@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2018
• First Posted: March 27, 2018
• Study Start: March 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 17, 2021

Record last verified: 2021-02

Locations

CN (1)