Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS) (NCT03591796) | Clinical Trial Compass
CompletedNot Applicable
Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)
China386 participantsStarted 2024-12-31
Plain-language 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.
Who can participate
Age range
1 Minute – 12 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
the incidence of bronchopulmonary dysplasia (BPD)
Timeframe: 28 days after birth or 36 weeks'gestational age
2
Death
Timeframe: 28 days after birth or 36 weeks'gestational age or before discharge
Trial details
NCT IDNCT03591796
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University