Clinical trial NCT03217162: Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)
Official title: Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS
RDS
Surfactant
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: death
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: bronchopulmonary dysplasia(BPD)
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
Secondary outcomes:
measure: Bayley Scales of Infant Development
timeFrame: at 2 months old and 2 years old
measure: haemodynamically significant patent ductusarteriosus (hsPDA)
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: retinopathy of prematurity (ROP)> 2nd stages
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: necrotizing enterocolitis (NEC) ≥ 2nd stages
timeFrame: at 36 weeks' gestational age or before discharge from hospital
measure: intraventricular hemorrhage(IVH)>2nd grades
timeFrame: at 36 weeks' gestational age or before discharge from hospital
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of neonatology, Children's hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References: