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

Study Overview
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Brief Summary
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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.

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

Conditions
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Infant, Newborn, NRDS

Intervention / Treatment
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* Drug: Surfactant, Pulmonary，Curosurf
* Other: Perinatal risk factors of NRDS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early preterm infants with RDS<br>gestational age<34 weeks | Drug: Surfactant, Pulmonary，Curosurf<br>* 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.<br>Other: Perinatal risk factors of NRDS<br>* Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.<br>|
| near term infants with RDS<br>34 weeks≤gestational age< 37 weeks | Drug: Surfactant, Pulmonary，Curosurf<br>* 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.<br>Other: Perinatal risk factors of NRDS<br>* Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.<br>|
| term infants with RDS<br>Gestational age ≥ 37 weeks | Drug: Surfactant, Pulmonary，Curosurf<br>* 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.<br>Other: Perinatal risk factors of NRDS<br>* Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic effect of pulmonary surfactant of infants at different gestational ages |  | January 1，2011 to December 30，2016 |