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

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ClinicalTrials.gov Identifier: NCT03479450
Recruitment Status : Not yet recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborators:
the first people hospital of Tibet autonomous region
the second people hospital of Lasa
the first people hospital of Shigatse
the first people hospital of Lasa
the people hospital of Linzhi
the people hospital of Laqu
Information provided by (Responsible Party):
Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Condition or disease Intervention/treatment
Surfactant Drug: surfactant

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.

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surfactant for Neonatal Respiratory Distress Syndrome at High Altitude Areas:a Prospective Cohort Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020



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


Primary Outcome Measures :
  1. the intubation rate [ Time Frame: one week ]
    to describe how many neonates might be intubated.

  2. the effect of surfactant for neonatal respiratory distress syndrome(NRDS) [ Time Frame: one week ]
    to describe the effect of surfactant for NRDS in high altitude areas.



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Ages Eligible for Study:   up to 1 Day   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
the preterm infants less than 37 weeks and diagnosed with NRDS were included in the study.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479450


Contacts
Contact: Ma Juan, MD 13508300283 petshi530@vip.163.com
Contact: Chen Long, PhD,MD 13883559467 476679422@qq.com

Locations
China, Chongqing
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
the first people hospital of Tibet autonomous region
the second people hospital of Lasa
the first people hospital of Shigatse
the first people hospital of Lasa
the people hospital of Linzhi
the people hospital of Laqu

Responsible Party: Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03479450     History of Changes
Other Study ID Numbers: surfactant for NRDS
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Hyaline Membrane Disease
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Respiratory System Agents