Evaluating fluid responsiveness in preterm infants using a non-invasive method
Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
University Hospital, Bordeaux · NCT06287710
This study is testing a new, gentle way to see if preterm infants with serious circulation problems need more fluids to help them without giving them too much.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 1 Minute to 5 Months |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06287710 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate a non-invasive marker for assessing fluid responsiveness in preterm infants with acute circulatory failure. By utilizing standardized abdominal compression, the study seeks to determine which infants would benefit from fluid expansion, thereby minimizing the risks associated with unnecessary fluid overload. The diagnostic accuracy of stroke volume variation induced by this method will be compared to the gold-standard test of cardiac index increase after fluid expansion. The goal is to improve fluid management in neonatal intensive care settings.
Who should consider this trial
Good fit: Ideal candidates for this study are premature newborns under 37 weeks of gestation who are hospitalized in neonatal intensive care and are prescribed fluid expansion.
Not a fit: Patients with acute cardiogenic pulmonary edema or significant hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective fluid management strategies for preterm infants, reducing the risk of complications associated with fluid overload.
How similar studies have performed: While there have been some studies exploring similar non-invasive methods, this specific approach is relatively novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux
- Bordeaux Hospital University — Bordeaux, France (RECRUITING)
Study contacts
- Principal investigator: Sophie CRAMAREGEAS — Bordeaux hospital University
- Study coordinator: Sophie CRAMAREGEAS, MD
- Email: sophie.cramaregeas@chu-bordeaux.fr
- Phone: 0557821269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks, Circulatory failure, volume expansion, echocardiography, Shock, goal-directed fluid management, preterm infants