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

NCT06287710 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-03-01

No results posted yet for this study

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).

Conditions

  • Premature Baby 26 to 32 Weeks
  • Premature Baby 33 to 36 Weeks

Interventions

PROCEDURE

Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).

Study of diagnostic accuracy (non-interventional, prospective, monocentric). Fluid expansion will be delayed for a few minutes while our index test is performed. After fluid expansion, patient will undergo an echocardiographic assessment of response to fluid expansion (gold-standard test). This will allow to test the diagnostic performance of the index test for the "prediction" of fluid responsiveness. The index test is the ΔSVi-AC: indexed percentage of stroke volume variation between baseline and during a standardized abdominal compression. Stroke volume will be assessed by transthoracic echocardiography. Patient will undergo 3 echocardiographic assessment: At baseline (stroke volume, cardiac output, left ventricular ejection fraction), During a standardized abdominal compression (stroke volume),After the 10 to 20ml/kg fluid expansion prescribed by the physician in charge (cardiac output).

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Sophie CRAMAREGEAS · Bordeaux hospital University

Eligibility

Min Age
1 Minute
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2024-11-17
Completion
2025-04-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06287710 on ClinicalTrials.gov