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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01296724
Enrollment
54
Registered
2011-02-15
Start date
2011-02-01
Completion date
2013-07-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care Unit Syndrome

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.

Interventions

OTHERMeasure 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.

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Days to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology2 years

Secondary

MeasureTime frame
Determine the normal intravesical pressure in critically ill children, with and without digestive pathology2 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATOROlivier Tirel

Rennes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026