ARDS, RDS, Surfactant
Conditions
Brief summary
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
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.
Interventions
DRUGsurfactant combined with mechanical ventilation (MV)
surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
mechanical ventilation (MV) is given to the infant with ARDS
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Minutes to 28 Days
Healthy volunteers
No
Inclusion criteria
1. infant less than 28 days 2. diagnosis of ARDS or RDS or both 3. informed parental consent has been obtained
Exclusion criteria
1. major congenital malformations or complex congenital heart disease or chromosomal abnormalities 2. transferred out of the neonatal intensive care unit without treatment 3. upper respiratory tract abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | at 36 weeks' gestational age or before discharge from hospital | neonates died |
| bronchopulmonary dysplasia(BPD) | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with BPD |
| BPD and/or death | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with BPD and/or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| necrotizing enterocolitis (NEC) ≥ 2nd stages | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with NEC ≥ 2nd stages |
| Bayley Scales of Infant Development | at 2 months old and 2 years old | the survival are assessed by Bayley Scales of Infant Development |
| intraventricular hemorrhage(IVH)>2nd grades | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with IVH \>2nd grades |
| haemodynamically significant patent ductusarteriosus (hsPDA) | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with hsPDA |
| retinopathy of prematurity (ROP)> 2nd stages | at 36 weeks' gestational age or before discharge from hospital | neonates were diagnosed with ROP\> 2nd stages |
Countries
China
Contacts
Primary ContactMa Juan, MD
Backup ContactMa Juan, MD
Outcome results
None listed