PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Intensive Care Unit Syndrome |
Other: Measure of intravesical pressure |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children |
- 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 ] [ Designated as safety issue: No ]
- Determine the normal intravesical pressure in critically ill children, with and without digestive pathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2011 |
| Arms | Assigned Interventions |
|---|---|
|
newborn with digestive pathology
Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology
|
Other: Measure of intravesical pressure
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.
|
|
Newborn without digestive pathology
Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology
|
Other: Measure of intravesical pressure
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.
|
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Preterm or term newborn admitted in paediatric intensive care unit
- With an urethral catheter
- Consent signed by parents
Exclusion Criteria:
- Weight > 4.5 kg
- Urinary tract or bladder pathology
Contacts and Locations| Contact: Olivier Tirel | 33-2-9926-3276 | olivier.tirel@chu-rennes.fr |
| France | |
| Rennes University Hospital | Recruiting |
| Rennes, Brittany, France, 35203 | |
| Contact: Olivier Tirel 33-2-9926-3276 olivier.tirel@chu-rennes.fr | |
| Principal Investigator: | Olivier Tirel | Rennes University Hospital |
More Information
No publications provided
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT01296724 History of Changes |
| Other Study ID Numbers: | 2010-A01346-33, LOC/10-17 |
| Study First Received: | February 14, 2011 |
| Last Updated: | November 14, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
ClinicalTrials.gov processed this record on May 16, 2013