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

Not Applicable

Completed

• Conditions: Intensive Care Unit Syndrome
• Interventions: Other: Measure of intravesical pressure

• Registration Number: NCT01296724
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Primary Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
newborn with digestive pathology	Measure of intravesical pressure	Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology
Newborn without digestive pathology	Measure of intravesical pressure	Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determine the normal intravesical pressure in critically ill children, with and without digestive pathology	2 years

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, Brittany, France