NCT03591796

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

Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 1 Minute – 12 Hours
• Healthy volunteers: Not accepted

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
• Conventional Mechanical Ventilation
• High Frequency Oscillation Ventilation

Interventions

Type	Name	Description
DEVICE	HFOV	Ventilated infants were randomized to HFOV
DEVICE	CMV	Ventilated infants were randomized to CMV.

Timeline

• Start date: 2024-12-31
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2018-07-19
• Last updated: 2025-07-09

Locations

1 site across 1 country: China