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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome (ARDS) and/or RDS : a Randomized Controlled Trial

Conditions
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Acute Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, High Frequency Oscillation Ventilation

Intervention / Treatment
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* Device: HFOV
* Device: CMV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 12 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFOV<br>Ventilated infants were randomized to HFOV. | Device: HFOV<br>* Infants were randomized to HFOV<br>|
| Active Comparator: CMV<br>Ventilated infants were randomized to CMV. | Device: CMV<br>* Infants were randomized to CMV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bronchopulmonary dysplasia (BPD) | neonate was diagnosed with BPD | 28 days after birth or 36 weeks'gestational age or before discharge | 
| death | the included preterm infants were dead | 28 days after birth or 36 weeks'gestational age or before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| air leak | the included preterm infants were diagnosed with air leak | 28 days after birth or 36 weeks'gestational age or before discharge | 
| the incidence of retinopathy of prematurity(ROP) | the included preterm infants were diagnosed with ROP | 28 days after birth or 36 weeks'gestational age or before discharge | 
| the incidence of neonatal necrotizing enterocolitis(NEC) | the included preterm infants were diagnosed with NEC | 28 days after birth or 36 weeks'gestational age or before discharge |