PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children

Study Overview
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Brief Summary
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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.

Official Title
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PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children

Conditions
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Intensive Care Unit Syndrome

Intervention / Treatment
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* Other: Measure of intravesical pressure
* Other: Measure of intravesical pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: newborn with digestive pathology<br>Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology | Other: Measure of intravesical pressure<br>* 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.<br>|
| Other: Newborn without digestive pathology<br>Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology | Other: Measure of intravesical pressure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the normal intravesical pressure in critically ill children, with and without digestive pathology |  | 2 years |