Acute Respiratory Distress Syndrome, Bronchopulmonary Dysplasia, High Frequency Oscillation Ventilation
Conditions
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.
Interventions
DEVICEHFOV
Infants were randomized to HFOV
DEVICECMV
Infants were randomized to CMV
Sponsors
Children's Hospital of Chongqing Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 12 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bronchopulmonary dysplasia (BPD) | 28 days after birth or 36 weeks'gestational age or before discharge | neonate was diagnosed with BPD |
| death | 28 days after birth or 36 weeks'gestational age or before discharge | the included preterm infants were dead |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| air leak | 28 days after birth or 36 weeks'gestational age or before discharge | the included preterm infants were diagnosed with air leak |
| the incidence of retinopathy of prematurity(ROP) | 28 days after birth or 36 weeks'gestational age or before discharge | the included preterm infants were diagnosed with ROP |
| the incidence of neonatal necrotizing enterocolitis(NEC) | 28 days after birth or 36 weeks'gestational age or before discharge | the included preterm infants were diagnosed with NEC |
Countries
China
Outcome results
None listed