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

R

Rennes University Hospital

Status

Completed

Conditions

Intensive Care Unit Syndrome

Treatments

Other: Measure of intravesical pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT01296724
2010-A01346-33
LOC/10-17

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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

Trial design

54 participants in 2 patient groups

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems