Intensive Care Unit SyndromeNCT01296724
PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
A study testing Measure of intravesical pressure in people with Intensive Care Unit Syndrome, run by Rennes University Hospital at 1 site in France.
Trial summary
Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH) associated with a new organ failure. The occurrence of this syndrome is not well known in infants. Preterm birth is frequently associated with gastrointestinal complications, particularly Necrotizing Enterocolitis. Read more about this study
- Who is it for?
- Ages 0 days to 3 months
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Measure of intravesical pressure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jul 2013
- Phase
- Interventional
- 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 0 days to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm or term newborn admitted in paediatric intensive care unit
- With an urethral catheter
- Consent signed by parents
Who cannot join
- Weight > 4.5 kg
- Urinary tract or bladder pathology
Trial locations and contacts
1 site in 1 country.
About this study
Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH) associated with a new organ failure. The occurrence of this syndrome is not well known in infants. Preterm birth is frequently associated with gastrointestinal complications, particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra abdominal pressure (IAP) increases and can participate in the occurrence of organ failures. Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis, could themselves be suffering from this syndrome. It would be interesting to make early diagnosis in order to optimize the management of these children. This requires reliable measurements methods and standards. Intravesical Pressure (IVP) is the most reliable validated indirect method to measure intra-abdominal pressure. In order to measure the IVP, the bladder must contain a minimum of liquid. However, using inappropriate volumes could give erroneous IAP readings. The optimal amount of saline to inject in older children, determined from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether this quantity is sufficient to obtain reliable and reproducible measurements of IVP in preterm and term.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Measure of intravesical pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of intravesical pressureOther
For the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various Intravesical pressure measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline.
Measure of intravesical pressureOther
For the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various IVP measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline.
| Study group | Role | What they receive |
|---|---|---|
| newborn with digestive pathology | Other | Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology Receives: Other: Measure of intravesical pressure |
| Newborn without digestive pathology | Other | Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology Receives: Other: Measure of intravesical pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology
Measured: 2 years
Secondary outcomes (1)
Determine the normal intravesical pressure in critically ill children, with and without digestive pathology
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Tirel, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296724
- Sponsor's protocol ID
- 2010-A01346-33
- Other IDs
- LOC/10-17
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2011
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
- ClinicalTrials.gov ID
- NCT01296724
- Acronym / sponsor ID
- 2010-A01346-33
- Conditions
- Intensive Care Unit Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Feb 2011 (estimated)
- 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.
Abdominal Compartment Syndrome (ASC) is defined by an Intra Abdominal Hypertension (IAH) associated with a new organ failure. The occurrence of this syndrome is not well known in infants. Preterm birth is frequently associated with gastrointestinal complications, particularly Necrotizing Enterocolitis. In this pathology it is likely that the intra abdominal pressure (IAP) increases and can participate in the occurrence of organ failures. Newborn, in particular with digestive malformation as diaphragmatic hernias, gastroschisis, could themselves be suffering from this syndrome. It would be interesting to make early diagnosis in order to optimize the management of these children. This requires reliable measurements methods and standards. Intravesical Pressure (IVP) is the most reliable validated indirect method to measure intra-abdominal pressure. In order to measure the IVP, the bladder must contain a minimum of liquid. However, using inappropriate volumes could give erroneous IAP readings. The optimal amount of saline to inject in older children, determined from pressure-volume curves study is 1 ml/kg. In preterm and term infants, this volume appear extremely low (e.g. 0 8cc if taking a child to 800 g). The question that arises is whether this quantity is sufficient to obtain reliable and reproducible measurements of IVP in preterm and term.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| newborn with digestive pathology | Other | Other: Measure of intravesical pressurePreterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology |
| Newborn without digestive pathology | Other | Other: Measure of intravesical pressurePreterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology |
Who may qualify
- Ages
- 0 days to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm or term newborn admitted in paediatric intensive care unit
- With an urethral catheter
- Consent signed by parents
Key exclusion criteria (2 listed)
- Weight > 4.5 kg
- Urinary tract or bladder pathology
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 |
|---|---|---|
| Measure of intravesical pressureFor the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various Intravesical pressure measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline. | Other | newborn with digestive pathology |
| Measure of intravesical pressureFor the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various IVP measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline. | Other | Newborn without digestive pathology |
Primary outcome
Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology
Time frame: 2 years
1 secondary outcome
Determine the normal intravesical pressure in critically ill children, with and without digestive pathology
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Olivier Tirel principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure of intravesical pressure in people with Intensive Care Unit Syndrome, run by Rennes University Hospital 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 12 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2026.