Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants… (NCT06287710) | Clinical Trial Compass
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Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
France20 participantsStarted 2024-01-17
Plain-language summary
In this study, the investigators aim to validate a non-invasive marker of fluid-responsiveness in preterm infants (term below 37 gestational week) with acute circulatory failure based on standardized abdominal compression. This would allow physicians to identify which patient could benefit from a fluid expansion, thus avoiding a potentially useless or even dangerous fluid expansion, leading to fluid overload. To this end, the investigators will evaluate the diagnostic accuracy (sensitivity and specificity) of stroke volume variation induced by standardized abdominal compression for the diagnosis of fluid responsiveness (based on the gold-standard test: significant increase in cardiac index after fluid expansion).
Who can participate
Age range
1 Minute – 5 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:
* Premature newborn under 37 weeks of amenorrhea hospitalized in neonatal intensive care
* Prescription of a 10 to 20ml/kg fluid expansion (crystalloid, blood products or albumin) by the physician in charge, whose goal would be to increase cardiac output (based on clinical, biological and/or echographic criteria).
Exclusion Criteria:
* Acute cardiogenic pulmonary edema
* Hemodynamic instability making the delay necessary for abdominal compression and ultrasonography dangerous for the patient
* Non corrected congenital cardiopathy, or inferior to 15 days postoperative. Intra-abdominal hypertension or painful abdominal palpation
* Abdominal surgery in the last 15 days
* Supine position contraindicated or deleterious
* No investigator available to assess ultrasonographic measures
* Impairment of echocardiographic acoustic window or restless patient making ultrasonography impossible
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
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness,
Timeframe: after abdominal compression, 30 minutes to 4 hours after baseline