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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01296724
First received: February 14, 2011
Last updated: November 25, 2013
Last verified: November 2013
  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

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Determine the normal intravesical pressure in critically ill children, with and without digestive pathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2011
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01296724

Locations
France
Rennes University Hospital
Rennes, Brittany, France, 35203
Sponsors and Collaborators
Rennes University Hospital
Investigators
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 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 23, 2014