Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

Not Applicable

Recruiting

• Conditions: RDS; Surfactant; ARDS
• Interventions: Drug: surfactant combined with mechanical ventilation (MV); Drug: mechanical ventilation (MV)

• Registration Number: NCT03217162
• Lead Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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.

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Study Start: 2017-08-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-23
• Last Update Posted: 2022-10-25
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surfactant combined with mechanical ventilation	surfactant combined with mechanical ventilation (MV)	surfactant is given to the infant with ARDS.
mechanical ventilation	mechanical ventilation (MV)	mechanical ventilation is given to the infant with ARDS.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bayley Scales of Infant Development	at 2 months old and 2 years old	the survival are assessed by Bayley Scales of Infant Development
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
necrotizing enterocolitis (NEC) ≥ 2nd stages	at 36 weeks' gestational age or before discharge from hospital	neonates were diagnosed with NEC ≥ 2nd stages
intraventricular hemorrhage(IVH)>2nd grades	at 36 weeks' gestational age or before discharge from hospital	neonates were diagnosed with IVH \>2nd grades

Trial Locations

Locations (1)

Department of neonatology, Children's hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China