Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)

NCT ID: NCT03372525

Last Updated: 2022-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2024-12-31

Brief Summary

Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.

Detailed Description

Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.

Conditions

Acute Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; High Frequency Oscillation Ventilation

Study Design

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

Study Groups

HFOV

Ventilated infants were randomized to HFOV.

Group Type: EXPERIMENTAL

HFOV

Intervention Type: DEVICE

Infants were randomized to HFOV

CMV

Ventilated infants were randomized to CMV.

Group Type: ACTIVE_COMPARATOR

CMV

Intervention Type: DEVICE

Infants were randomized to CMV

Interventions

HFOV

Infants were randomized to HFOV

Intervention Type: DEVICE

CMV

Infants were randomized to CMV

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• For a neonate to be included, the following four criteria must be fulfilled: (1)gestational age (GA) between 26+0 and 32+0 weeks (estimated on the postmenstrual date and early gestation ultrasonographic findings); (2)Birth weight less than 2000g; (3) assisted with CMV within 12 h after birth; (4)diagnosis with ARDS and/or RDS. (5)stabilization before randomization within 12 h after birth: FiO2<=0.30, pH>7.20, PaCO2<=60 mmHg, Paw <=7-8 cmH2O;

Exclusion Criteria

• neonates with at least one of the following criteria are not eligible for the study: (1) Neonates who only needed noninvasive ventilation; (2) major congenital anomalies or chromosomal abnormalities; (3) neuromuscular diseases; (4) upper respiratory tract abnormalities; (5) need for surgery known before the first extubation; (6) Grade Ⅲ-IV-intraventricular hemorrhage (IVH); (7) congenital lung diseases or malformations or pulmonary hypoplasia.

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 12 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Chen Long,MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Long Chen, MD

Role: primary

neuroclong@126.com

8613883559467

Shi Yuan, PhD,MD

Role: backup

Other Identifiers

MV for ARDS

Identifier Type: -

Identifier Source: org_study_id