Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis (NCT03298217) | Clinical Trial Compass
CompletedNot Applicable
Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis
France50 participantsStarted 2017-11-21
Plain-language summary
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).
PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC). Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.
Who can participate
Age range
6 Months
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:
* Infants up to 6 months old, with AVB according to conventional clinical criteria;
* Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de Villeneuve University Hospital in Montpellier (France);
* Supported with HFNC, according to the department's protocol (2 \< m-WCAS \< 5);
* Not requiring immediate intubation for invasive ventilation;
* Signed parental consent.
Exclusion Criteria:
* Infant with heart disease, cystic fibrosis or neuromuscular disorder;
* Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP) or with HFNC and without possibility of weaning, including for a few minutes;
* Intolerance of the spirometry mask.
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
Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
Timeframe: 1 day but within 24 hours of patient admission