Clinical trial NCT04777760: Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
Official title: Surfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Distress Syndrome
Preterm Birth
Acute Respiratory Distress Syndrome
Surfactant Dysfunction
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-03-02
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: bronchopulmonary dysplasia(BPD)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: death
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: BPD and/or death
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: the predictive powers of one dose of surfactant to diagnose NRDS
timeFrame: seven days after birth
measure: the predictive powers of two and more doses of surfactant to diagnose NARDS
timeFrame: seven days after birth
Secondary outcomes:
measure: intraventricular hemorrhage(IVH)
timeFrame: before discharge or 36 weeks' gestational age
measure: air leak
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: periventricular leukomalacia(PVL)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: necrotizing enterocolitis(NEC)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: patent ductus arteriosis(PDA)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: late-onset sepsis(LOS)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chen
state: Chongqing
Study officials:
References: