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

Army Medical University of People's Liberation Army

Status: Completed

Conditions: High Frequency Oscillation Ventilation; Acute Respiratory Distress Syndrome; Conventional Mechanical Ventilation

Treatments: Device: HFOV; Device: CMV

Study type: Interventional

Funder types: Other

Identifiers

NCT03591796

invasive ventilation for ARDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 386 patients

Sex: All

Ages: 1 minute to 12 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age (GA) between 25+0 and 34+0 weeks;
• Assisted with CMV within 12 h after birth;
• Diagnosis with ARDS;
• Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg and > 35% of hematocrit

Exclusion criteria

• parents' decision not to participate;
• Major congenital anomalies or chromosomal abnormalities;
• Upper respiratory tract abnormalities;
• need for surgery before randomization;
• Grade Ⅲ-IV-intraventricular hemorrhage (IVH).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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386 participants in 2 patient groups

HFOV

Experimental group

Description:

Ventilated infants were randomized to HFOV.

Treatment:

Device: HFOV

CMV

Active Comparator group

Description:

Ventilated infants were randomized to CMV.

Treatment:

Device: CMV