A Multicenter Clinical Study on the Comparison of the Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University1 site in 1 country1,500 target enrollmentJanuary 1, 2011

ConditionsInfant, Newborn, NRDS

InterventionsSurfactant, Pulmonary，Curosurf Perinatal risk factors of NRDS

DrugsSurfactant, Pulmonary，Curosurf

Overview

Phase: Not Applicable
Intervention: Surfactant, Pulmonary，Curosurf
Conditions: Infant, Newborn, NRDS
Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Enrollment: 1500
Locations: 1
Primary Endpoint: therapeutic effect of pulmonary surfactant of infants at different gestational ages
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Since exogenous surfactant replacement therapy was first used to prevent neonatal respiratory distress syndrome (NRDS)，it has become the main method of treatment of NRDS. However, in some infants, death is inevitable despite intensive care and surfactant replacement therapy, especially in near-term and term infants. The first goal of our study is to compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS. The second goal of our study is to further analyze the risk factors and causes of RDS in early preterm infants and near term/term infants.

Registry

clinicaltrials.gov

Start Date

January 1, 2011

End Date

March 1, 2018

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Responsible Party

Principal Investigator

Li Wang

Daping Hospital

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Eligibility Criteria

Inclusion Criteria

•Infants with RDS who received surfactant therapy were recruited between January 2011 and December 2016.

Exclusion Criteria

•Infants were excluded if they had any congeni- tal malformation, inherited metabolic abnormality, intrauterine infection, Rh/Rh incompatibility, pneumonia, pulmonary hypertension, meconium aspiration syndrome, or asphyxia.