Premature Baby 26 to 32 WeeksFRENCH-PREMANCT06287710
Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
An observational study of Premature Baby 26 to 32 Weeks and Premature Baby 33 to 36 Weeks, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 5 months
- Conditions the study is for
- Premature Baby 26 to 32 Weeks, Premature Baby 33 to 36 Weeks
- What is being tested?
- Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2024to 17 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 5 months
- All sexes
- No healthy volunteers
- Child
Study population: As this is a pilot study in a population of premature infants (term bellow 37 weeks of amenorrhea), the projected number of patients included will be 20, based on the department's active patient file, in order to have a minimum of 40 fluid expansion required for the study.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Bordeaux Hospital University
Bordeaux, 33076
Sophie CRAMAREGEAS, MD, 0557821269
sophie.cramaregeas@chu-bordeaux.fr
About this study
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).
Read the detailed description
Fluid expansion is the cornerstone of acute circulatory failure treatment in children and preterm infants with acute circulatory failure. Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion especially for preterm infants such as PDA, chronic lung disease and mortality. Currently, the search for indicators to predict fluid responsiveness is a major issue in neonatal intensive care. These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. However, in children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.
Thus, there is a need of reliable preloads markers to guide intravenous volume rescusitation in neonates.
In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in preterm infants (<37WA) with acute circulatory failure, hospitalized in neonatal intensive care unit for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.
In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion.
- Being tested
- Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).
- Keywords
- Circulatory failure (shock), volume expansion, echocardiography, Shock, goal-directed fluid management, preterm infants
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).Procedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness,
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between SV after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment.
Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment.
value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test)
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Secondary outcomes (1)
Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness
Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test) in preterm infants.
Comparison of the diagnostic accuracy of these tests.
Measured: after abdominal compression, 30 minutes to 4 hours after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start17 Jan 2024
- Primary completion17 Nov 2024 (estimated)
- Study completion17 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Baby 26 to 32 WeeksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie CRAMAREGEAS, Principal investigator, Bordeaux hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287710
- Sponsor's protocol ID
- CHUBX 2023/32
- Acronym
- FRENCH-PREMA
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gotchac J, Jammet N, Gerard R, Brousse D, Egger J, Le Cabec E, Renard C, Tandonnet O, Amedro P, Cramaregeas S. Calibrated abdominal compression to assess fluid responsiveness in extremely and very preterm neonates: a pilot study. Front Pediatr. 2026 Apr 9;14:1711753. doi: 10.3389/fped.2026.1711753. eCollection 2026.
PubMed 42038207
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness Evaluation by a Non-invasive Method in Children, Extended to PREterm Infants - FRENCH-PREMA
- ClinicalTrials.gov ID
- NCT06287710
- Acronym / sponsor ID
- FRENCH-PREMA / CHUBX 2023/32
- Keywords
- Circulatory failure (shock), volume expansion, echocardiography, Shock, goal-directed fluid management, preterm infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 17 Nov 2024 (estimated)
- Study completion
- 17 Apr 2025 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Fluid expansion is the cornerstone of acute circulatory failure treatment in children and preterm infants with acute circulatory failure. Although this therapy drastically reduced mortality, several studies in recent years have highlighted the adverse effects of excessive fluid expansion especially for preterm infants such as PDA, chronic lung disease and mortality. Currently, the search for indicators to predict fluid responsiveness is a major issue in neonatal intensive care. These indicators are based on Franck-Starling's law: if small changes in preload lead to an increase in cardiac output, then fluid responsiveness can be expected. However, in children, the only validated indicator (respiratory variability of peak aortic velocity) can only be used in the absence of any spontaneous respiratory movement, a rare situation in practice. Recently, two pediatric studies investigated a simple clinical test: hepatic or abdominal compression. This clinical maneuver, by increasing venous return via mobilization of the hepato-splanchnic reserve, induces a transient and reversible preload increase. The evaluation of the hemodynamic effects of this "endogenous fluid expansion" allowed, according to the authors, to accurately predict fluid responsiveness. However, several factors reduce the applicability of these results: the small number of studies on this subject, the smaller volume of fluid used than in clinical practice, and the population studied, composed almost exclusively of children in postoperative of cardiac surgery.
Thus, there is a need of reliable preloads markers to guide intravenous volume rescusitation in neonates.
In this study, the investigators will evaluate the diagnostic accuracy of abdominal compression for the diagnosis of fluid responsiveness in preterm infants (<37WA) with acute circulatory failure, hospitalized in neonatal intensive care unit for a medical or a non-cardiac surgical condition, for whom a fluid expansion was prescribed by the physician in charge. The index test will be the stroke volume variation following a standardized abdominal compression (before fluid expansion). The gold standard test will be the variation of cardiac output between baseline and after fluid expansion, a variation > 15% defining fluid responsiveness.
In this non interventional study of diagnostic accuracy, patients will undergo an extra echocardiographic assessment, but no supplemental blood test or invasive parameters will be collected. Simple clinical parameters will be collected within 4 hours after the fluid expansion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study of diagnostic accuracy | – | Procedure: Non interventional study (study of diagnostic accuracy with an extra echocardiographic assessment).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. |
Who may qualify
- Ages
- 1 minute to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- As this is a pilot study in a population of premature infants (term bellow 37 weeks of amenorrhea), the projected number of patients included will be 20, based on the department's active patient file, in order to have a minimum of 40 fluid expansion required for the study.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Procedure or surgery | study of diagnostic accuracy |
Primary outcome
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness,
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test) Index test (ΔSVi-AC) will be calculated as the difference between SV after abdominal compression and SV at baseline, divided by SV at baseline (%). SV will be measured by echocardiographic assessment. Gold-standard test (ΔCO-FE) will be calculated as the difference between CO after fluid expansion and CO at baseline, divided by CO at baseline (%). CO will be measured by echocardiographic assessment. value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, defined by an increase of cardiac output > 15% after fluid expansion (ΔCO-FE > 15%, gold-standard test)
1 secondary outcome
Diagnostic accuracy of the SAV mean and the ΔPeak for the diagnosis of fluid responsiveness
Time frame: after abdominal compression, 30 minutes to 4 hours after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Derived from this study: PubMed 42038207Gotchac J, Jammet N, Gerard R, Brousse D, Egger J, Le Cabec E, Renard C, Tandonnet O, Amedro P, Cramaregeas S. Calibrated abdominal compression to assess fluid responsiveness in extremely and very preterm neonates: a pilot study. Front Pediatr. 2026 Apr 9;14:1711753. doi: 10.3389/fped.2026.1711753. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie CRAMAREGEAS principal investigator
Bordeaux hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Baby 26 to 32 Weeks and Premature Baby 33 to 36 Weeks, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie CRAMAREGEAS, MD (0557821269, sophie.cramaregeas@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of the index test (ΔSVi-AC) for the diagnosis of fluid responsiveness, (time frame: after abdominal compression, 30 minutes to 4 hours after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 29 Oct 2026.