Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Enrollment
- 386
- Locations
- 1
- Primary Endpoint
- Death
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Chen Long,MD
Principal Investigator
Children's Hospital of Chongqing Medical University
Eligibility Criteria
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).
Outcomes
Primary Outcomes
Death
Time Frame: 28 days after birth or 36 weeks'gestational age or before discharge
the included preterm infants were dead
the incidence of bronchopulmonary dysplasia (BPD)
Time Frame: 28 days after birth or 36 weeks'gestational age
the included neonate was diagnosed with BPD
Secondary Outcomes
- the incidence of neonatal necrotizing enterocolitis(NEC)(28 days after birth or 36 weeks'gestational age or before discharge)
- the incidence of retinopathy of prematurity(ROP)(28 days after birth or 36 weeks'gestational age or before discharge)
- Intraventricular hemorrhage(28 days after birth or 36 weeks'gestational age or before discharge)
- composite mortality/BPD(28 days after birth or 36 weeks'gestational age or before discharge)
- the incidence of airleak(28 days after birth or 36 weeks'gestational age or before discharge)