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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
mechanical ventilation (MV) is given to the infant with ARDS
Department of neonatology, Children's hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGdeath
neonates died
Time frame: at 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia(BPD)
neonates were diagnosed with BPD
Time frame: at 36 weeks' gestational age or before discharge from hospital
BPD and/or death
neonates were diagnosed with BPD and/or death
Time frame: at 36 weeks' gestational age or before discharge from hospital
Bayley Scales of Infant Development
the survival are assessed by Bayley Scales of Infant Development
Time frame: at 2 months old and 2 years old
haemodynamically significant patent ductusarteriosus (hsPDA)
neonates were diagnosed with hsPDA
Time frame: at 36 weeks' gestational age or before discharge from hospital
retinopathy of prematurity (ROP)> 2nd stages
neonates were diagnosed with ROP\> 2nd stages
Time frame: at 36 weeks' gestational age or before discharge from hospital
necrotizing enterocolitis (NEC) ≥ 2nd stages
neonates were diagnosed with NEC ≥ 2nd stages
Time frame: at 36 weeks' gestational age or before discharge from hospital
intraventricular hemorrhage(IVH)>2nd grades
neonates were diagnosed with IVH \>2nd grades
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Time frame: at 36 weeks' gestational age or before discharge from hospital