Surfactant for Neonate With Acute Respiratory Distress Syndrome (ARDS)

NCT ID: NCT03217162

Last Updated: 2022-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2024-12-30

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.

Conditions

ARDS; RDS; Surfactant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

surfactant combined with mechanical ventilation

surfactant is given to the infant with ARDS.

Group Type: EXPERIMENTAL

surfactant combined with mechanical ventilation (MV)

Intervention Type: DRUG

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

mechanical ventilation

mechanical ventilation is given to the infant with ARDS.

Group Type: ACTIVE_COMPARATOR

mechanical ventilation (MV)

Intervention Type: DRUG

mechanical ventilation (MV) is given to the infant with ARDS

Interventions

surfactant combined with mechanical ventilation (MV)

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

Intervention Type: DRUG

mechanical ventilation (MV)

mechanical ventilation (MV) is given to the infant with ARDS

Intervention Type: DRUG

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

• Minimum Eligible Age: 30 Minutes
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Ma Juan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shi Yuan, PhD,MD

Role: STUDY_DIRECTOR

Children's Hospital of Chongqing Medical University

Locations

Department of neonatology, Children's hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ma Juan, MD

Role: CONTACT

476679422@qq.com

13883559467

Ma Juan, MD

Role: CONTACT

476679422@qq.com

1388.559467

Facility Contacts

Juan Ma, physician

Role: primary

zoe330@163.com

18680887330

Other Identifiers

surfactant for ARDS

Identifier Type: -

Identifier Source: org_study_id