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

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 Overview

• Status: Completed
• Conditions: Intensive Care Unit Syndrome
• Intervention / Treatment: Other: Measure of intravesical pressure; Other: Measure of intravesical pressure

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Brittany
    • Rennes, Brittany, France, 35203
      • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.; 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.
Other: 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 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: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Olivier Tirel, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 26, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 2010-A01346-33; LOC/10-17