Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

ARDS Clinical Trial

Official title:

Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217162
• Other study ID #: surfactant for ARDS
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Ma Juan, MD
• Phone: 13883559467
• Email: 476679422[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Minutes to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• ARDS
• RDS
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Surfactant

Intervention

Drug:
• surfactant combined with mechanical ventilation (MV)
surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
• mechanical ventilation (MV)
mechanical ventilation (MV) is given to the infant with ARDS

Locations

Country	Name	City	State
China	Department of neonatology, Children's hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	neonates died	at 36 weeks' gestational age or before discharge from hospital
Primary	bronchopulmonary dysplasia(BPD)	neonates were diagnosed with BPD	at 36 weeks' gestational age or before discharge from hospital
Primary	BPD and/or death	neonates were diagnosed with BPD and/or death	at 36 weeks' gestational age or before discharge from hospital
Secondary	Bayley Scales of Infant Development	the survival are assessed by Bayley Scales of Infant Development	at 2 months old and 2 years old
Secondary	haemodynamically significant patent ductusarteriosus (hsPDA)	neonates were diagnosed with hsPDA	at 36 weeks' gestational age or before discharge from hospital
Secondary	retinopathy of prematurity (ROP)> 2nd stages	neonates were diagnosed with ROP> 2nd stages	at 36 weeks' gestational age or before discharge from hospital
Secondary	necrotizing enterocolitis (NEC) = 2nd stages	neonates were diagnosed with NEC = 2nd stages	at 36 weeks' gestational age or before discharge from hospital
Secondary	intraventricular hemorrhage(IVH)>2nd grades	neonates were diagnosed with IVH >2nd grades	at 36 weeks' gestational age or before discharge from hospital