Post-Extubation Assessment of Clinical Stability in ELBW Infants (NCT06037083) | Clinical Trial Compass
RecruitingNot Applicable
Post-Extubation Assessment of Clinical Stability in ELBW Infants
Canada20 participantsStarted 2024-10-29
Plain-language summary
This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.
Who can participate
Age range
28 Weeks
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:
* Birth weight \< 1000g and gestational age \< 28+0 weeks,
* Received mechanical ventilation within the first 72h of life,
* Undergoing their first planned extubation within the first 6 weeks of life.
Exclusion Criteria:
\- Congenital anomalies and congenital heart disorders.
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
Recruitment rate
Timeframe: 168 hours
2
Consent rate
Timeframe: 168 hours
3
Acceptability of the multimodal monitoring approach
Timeframe: 168 hours
Trial details
NCT IDNCT06037083
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre