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

February 14, 2011
November 25, 2013
February 2011
July 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01296724 on ClinicalTrials.gov Archive Site
Determine the normal intravesical pressure in critically ill children, with and without digestive pathology [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
PREMAPIV : Intravesical Pressure Variation at Different Bladder Instillation Volumes in Newborn Children
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Intensive Care Unit Syndrome
  • 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.
  • newborn with digestive pathology
    Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology
    Intervention: Other: Measure of intravesical pressure
  • Newborn without digestive pathology
    Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology
    Intervention: Other: Measure of intravesical pressure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
Not Provided
July 2013   (final data collection date for primary outcome measure)

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
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01296724
2010-A01346-33, LOC/10-17
Not Provided
Rennes University Hospital
Rennes University Hospital
Not Provided
Principal Investigator: Olivier Tirel Rennes University Hospital
Rennes University Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP