Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 5 months
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Bordeaux Hospital University
RECRUITING
Bordeaux
Contact Information
Primary
Sophie CRAMAREGEAS, MD
sophie.cramaregeas@chu-bordeaux.fr
0557821269
Backup
Géraldine ROBERT
geraldine.robert@chu-bordeaux.fr
055821500
Time Frame
Start Date: 2024-01-17
Estimated Completion Date: 2025-04-17
Participants
Target number of participants: 20
Treatments
study of diagnostic accuracy
Patients included in this study would have received fluid expansion in all cases, as the prescription of 10 to 20ml/kg fluid expansion by the physician in charge is the main inclusion criterion.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov