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

Intensive Care Unit Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296724
• Other study ID #: 2010-A01346-33
• Secondary ID: LOC/10-17
• Status: Completed
• Phase: N/A
• First received: February 14, 2011
• Last updated: November 25, 2013
• Start date: February 2011

Study information

• Verified date: November 2013
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology		2 years	No
Secondary	Determine the normal intravesical pressure in critically ill children, with and without digestive pathology		2 years	No