UnknownNot Applicable

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

China400 participantsStarted 2018-12-01

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: * 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.

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

bronchopulmonary dysplasia (BPD)

Timeframe: 28 days after birth or 36 weeks'gestational age or before discharge

death

Timeframe: 28 days after birth or 36 weeks'gestational age or before discharge

Trial details

NCT IDNCT03372525

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Acute Respiratory Distress Syndrome trials

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.