Status:
UNKNOWN
Invasive Ventilation Strategies for Neonates With Acute Respiratory Distress Syndrome Syndrome (ARDS)
Lead Sponsor:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Collaborating Sponsors:
Children's Hospital of Chongqing Medical University
Conditions:
Acute Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Eligibility:
All Genders
1-12 years
Phase:
NA
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 need...
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, invas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03372525
Start Date
December 1 2018
End Date
December 31 2024
Last Update
October 14 2022
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042