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

NCT01296724 | Completed

• 2 other identifiers: 2010-A01346-33LOC/10-17
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Syndrome

Outcome Measures

Primary Outcomes (1)

• Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology

  2 years

Secondary Outcomes (1)

• Determine the normal intravesical pressure in critically ill children, with and without digestive pathology

  2 years

Study Arms (2)

newborn with digestive pathology

OTHER

Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and digestive pathology

Other: Measure of intravesical pressure

Newborn without digestive pathology

OTHER

Preterm or term newborn admitted in paediatric intensive care unit with an urethral catheter and without digestive pathology

Other: Measure of intravesical pressure

Interventions

Measure of intravesical pressure OTHER

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 with digestive pathology

Eligibility Criteria

• Age: 0 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm or term newborn admitted in paediatric intensive care unit
• With an urethral catheter
• Consent signed by parents

You may not qualify if:

• Weight \> 4.5 kg
• Urinary tract or bladder pathology

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35203, France

Location

Study Officials

• Olivier Tirel

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (1)