Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: ARDS; RDS; Surfactant
• Intervention / Treatment: Drug: surfactant combined with mechanical ventilation (MV); Drug: mechanical ventilation (MV)

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ma Juan, MD; Phone Number: 13883559467; Email: 476679422@qq.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Department of neonatology, Children's hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 minutes to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: surfactant combined with mechanical ventilation; surfactant is given to the infant with ARDS.	Drug: surfactant combined with mechanical ventilation (MV); surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
Active Comparator: mechanical ventilation; mechanical ventilation is given to the infant with ARDS.	Drug: mechanical ventilation (MV); mechanical ventilation (MV) is given to the infant with ARDS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
death	neonates died	at 36 weeks' gestational age or before discharge from hospital
bronchopulmonary dysplasia(BPD)	neonates were diagnosed with BPD	at 36 weeks' gestational age or before discharge from hospital
BPD and/or death	neonates were diagnosed with BPD and/or death	at 36 weeks' gestational age or before discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bayley Scales of Infant Development	the survival are assessed by Bayley Scales of Infant Development	at 2 months old and 2 years old
haemodynamically significant patent ductusarteriosus (hsPDA)	neonates were diagnosed with hsPDA	at 36 weeks' gestational age or before discharge from hospital
retinopathy of prematurity (ROP)> 2nd stages	neonates were diagnosed with ROP> 2nd stages	at 36 weeks' gestational age or before discharge from hospital
necrotizing enterocolitis (NEC) ≥ 2nd stages	neonates were diagnosed with NEC ≥ 2nd stages	at 36 weeks' gestational age or before discharge from hospital
intraventricular hemorrhage(IVH)>2nd grades	neonates were diagnosed with IVH >2nd grades	at 36 weeks' gestational age or before discharge from hospital

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Investigators: Study Director: Shi Yuan, PhD,MD, Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): December 30, 2024
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 13, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Respiratory System Agents; Pulmonary Surfactants
• Other Study ID Numbers: surfactant for ARDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No