Acute Respiratory Distress Syndrome, Preterm Birth, Respiratory Distress Syndrome, Surfactant Dysfunction
Conditions
Brief summary
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
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.
Interventions
DRUGone dose of surfactant replacement
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
DRUGtwo and more doses of surfactant replacement
the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant
Sponsors
Children's Hospital of Chongqing Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 24 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BPD and/or death | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with BPD and/or death |
| bronchopulmonary dysplasia(BPD) | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with BPD |
| death | at 36 weeks' gestational age or before discharge from hospital | the preterm infants die |
| the predictive powers of one dose of surfactant to diagnose NRDS | seven days after birth | the sensitivity and accuracy of one dose of surfactant to diagnose NRDS |
| the predictive powers of two and more doses of surfactant to diagnose NARDS | seven days after birth | the sensitivity and accuracy of two and more doses of surfactant to diagnose NARDS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| intraventricular hemorrhage(IVH) | before discharge or 36 weeks' gestational age | the preterm infants will be diagnosed with IVH |
| late-onset sepsis(LOS) | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with LOS |
| air leak | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with air leak |
| periventricular leukomalacia(PVL) | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with PVL |
| necrotizing enterocolitis(NEC) | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with NEC |
| patent ductus arteriosis(PDA) | at 36 weeks' gestational age or before discharge from hospital | the preterm infants will be diagnosed with PDA |
Countries
China
Contacts
Primary ContactChen Long, MD, PhD
Outcome results
None listed