Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Study Overview
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Brief Summary
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Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of surfactant is not clear. This study aimed to determine whether ARDS neonate would benefit from surfactant when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Detailed Description
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To date, surfactant is not recommended to adult and pediatric ARDS. Meantime, systematic review indicates that surfactant does not demonstrate statistically significant beneficial effects on reducing the mortality and the rate of bronchopulmonary dysplasia(BPD) in term and late preterm infants with meconium aspiration syndrome. Therefore, a reasonable speculation is that preterm infants with ARDS do not benefit from one dose of surfactant. And the speculation can explain why not all preterm infants with respiratory distress can be beneficial from surfactant. In the era of pre-ARDS, the preterm infants fulfilling the definition of ARDS may have been considered as respiratory distress syndrome (ARDS) in the first three days after birth. According to the diagnostic criteria of neonatal ARDS, a key procedure for diagnosis of neonatal ARDS is to exclude the newborn infants with RDS. But no detailed procedures are available to differentiate RDS from ARDS according the guideline of european RDS and definition of neonatal ARDS. Therefore, there are two aim in the present study. 1. to proposel a new definition of RDS; 2. to assess the beneficial effects of surfactant on neonatal ARDS.

Official Title
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Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial

Conditions
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ARDS, RDS, Surfactant

Intervention / Treatment
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* Drug: surfactant combined with mechanical ventilation (MV)
* Drug: mechanical ventilation (MV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infant less than 28 days diagnosis of ARDS or RDS or both informed parental consent has been obtained Exclusion Criteria: major congenital malformations or complex congenital heart disease or chromosomal abnormalities transferred out of the neonatal intensive care unit without treatment upper respiratory tract abnormalities

Ages Eligible for Study
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Minimum Age: 30 Minutes
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surfactant combined with mechanical ventilation<br>surfactant is given to the infant with ARDS. | Drug: surfactant combined with mechanical ventilation (MV)<br>* surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS<br>|
| Active Comparator: mechanical ventilation<br>mechanical ventilation is given to the infant with ARDS. | Drug: mechanical ventilation (MV)<br>* mechanical ventilation (MV) is given to the infant with ARDS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | neonates died | at 36 weeks' gestational age or before discharge from hospital | 
| bronchopulmonary dysplasia(BPD) | neonates were diagnosed with BPD | at 36 weeks' gestational age or before discharge from hospital | 
| BPD and/or death | neonates were diagnosed with BPD and/or death | at 36 weeks' gestational age or before discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Infant Development | the survival are assessed by Bayley Scales of Infant Development | at 2 months old and 2 years old | 
| haemodynamically significant patent ductusarteriosus (hsPDA) | neonates were diagnosed with hsPDA | at 36 weeks' gestational age or before discharge from hospital | 
| retinopathy of prematurity (ROP)> 2nd stages | neonates were diagnosed with ROP> 2nd stages | at 36 weeks' gestational age or before discharge from hospital | 
| necrotizing enterocolitis (NEC) ≥ 2nd stages | neonates were diagnosed with NEC ≥ 2nd stages | at 36 weeks' gestational age or before discharge from hospital | 
| intraventricular hemorrhage(IVH)>2nd grades | neonates were diagnosed with IVH >2nd grades | at 36 weeks' gestational age or before discharge from hospital |