NCT03385863

Efficacy of Surfactant and Perinatal Risk Factors in NRDS With Different Gestational Ages

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Infant, Newborn, NRDS

Interventions

Type	Name	Description
DRUG	Surfactant, Pulmonary，Curosurf	All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. 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.
OTHER	Perinatal risk factors of NRDS	Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.

Timeline

• Start date: 2011-01-01
• Primary completion: 2016-12-30
• Completion: 2018-03-01
• First posted: 2017-12-29
• Last updated: 2017-12-29

Locations

1 site across 1 country: China