About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
major congenital anomalies
chromosomal abnormalities
upper respiratory tract abnormalities
Trial population
Preterm infants diagnosed with NRDS or NARDS were eligible. The diagnosis of NARDS was according to the criteria established by Montreux conference in 2017.The diagnosis of NRDS was according to the criteria established by European Consensus Guideline for the management of NRDS in 2019
Trial design
Cohort
Prospective
Treatments tested in this trial
one dose of surfactant replacement
Drugthe preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
two and more doses of surfactant replacement
Drugthe preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant
Treatment groups
Trial outcomes
Primary outcomes
bronchopulmonary dysplasia(BPD)
the preterm infants will be diagnosed with BPD
death
the preterm infants die
BPD and/or death
the preterm infants will be diagnosed with BPD and/or death
the predictive powers of one dose of surfactant to diagnose NRDS
the sensitivity and accuracy of one dose of surfactant to diagnose NRDS
Secondary outcomes
intraventricular hemorrhage(IVH)
the preterm infants will be diagnosed with IVH
air leak
the preterm infants will be diagnosed with air leak
periventricular leukomalacia(PVL)
the preterm infants will be diagnosed with PVL
necrotizing enterocolitis(NEC)
the preterm infants will be diagnosed with NEC
Sponsors and contacts
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Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead sponsor
Children's Hospital of Chongqing Medical University
Sponsor institution
Children's Hospital of Chongqing Medical University
Collaborator