Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

Study Overview
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Brief Summary
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In preterm infants with neonatal respiratory distress syndrome (NRDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal mortality. Nowadays, PS is commonly used in newborn infants with respiratory distress, but the incidences of bronchopulmonary dysplasia(BPD) and/or death are inconsistent. The result indicates that not all preterm infants with respiratory distress can be beneficial from PS. In 2017, the international neonatal ARDS (NARDS) collaborative group provides the first consensus definition for NARDS. And whether or not PS being beneficial for preterm infants with NARDS remains unknown.

Detailed Description
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To date, PS is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that PS does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of BPD in term and late preterm infants with meconium aspiration syndrome(MAS). Therefore, a reasonable speculation is that preterm infants with NARDS do not benefit from one dose of PS. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as NRDS in the first three days after birth. According to the diagnostic criteria of NARDS, a key procedure for diagnosis of NARDS is to exclude the newborn infants with NRDS. But no detailed procedures are available to differentiate NRDS from NARDS.

Official Title
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Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)

Conditions
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Respiratory Distress Syndrome, Preterm Birth, Acute Respiratory Distress Syndrome, Surfactant Dysfunction

Intervention / Treatment
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* Drug: one dose of surfactant replacement
* Drug: two and more doses of surfactant replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligibility requirements for neonates were as follows: The gestational age is less than 37 weeks and admitted to neonatal intensive care unit(NICU) in 24 h after birth The neonates will be diagnosed with NRDS or NARDS The neonates will be at least administrated one dose of surfactant Exclusion Criteria: one of the following criteria will be needed major congenital anomalies chromosomal abnormalities upper respiratory tract abnormalities

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 24 Hours

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| one dose of surfactant<br>the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant | Drug: one dose of surfactant replacement<br>* the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant<br>|
| two and more doses of surfactant<br>the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant | Drug: two and more doses of surfactant replacement<br>* the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia(BPD) | the preterm infants will be diagnosed with BPD | at 36 weeks' gestational age or before discharge from hospital | 
| death | the preterm infants die | at 36 weeks' gestational age or before discharge from hospital | 
| BPD and/or death | the preterm infants will be diagnosed with BPD and/or death | at 36 weeks' gestational age or before discharge from hospital | 
| the predictive powers of one dose of surfactant to diagnose NRDS | the sensitivity and accuracy of one dose of surfactant to diagnose NRDS | seven days after birth | 
| the predictive powers of two and more doses of surfactant to diagnose NARDS | the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS | seven days after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraventricular hemorrhage(IVH) | the preterm infants will be diagnosed with IVH | before discharge or 36 weeks' gestational age | 
| air leak | the preterm infants will be diagnosed with air leak | at 36 weeks' gestational age or before discharge from hospital | 
| periventricular leukomalacia(PVL) | the preterm infants will be diagnosed with PVL | at 36 weeks' gestational age or before discharge from hospital | 
| necrotizing enterocolitis(NEC) | the preterm infants will be diagnosed with NEC | at 36 weeks' gestational age or before discharge from hospital | 
| patent ductus arteriosis(PDA) | the preterm infants will be diagnosed with PDA | at 36 weeks' gestational age or before discharge from hospital | 
| late-onset sepsis(LOS) | the preterm infants will be diagnosed with LOS | at 36 weeks' gestational age or before discharge from hospital |