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临床试验/NCT01296724
NCT01296724已完成不适用

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

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
2
主要终点
Determinate the optimal volume of saline injection in the bladder for measuring intravesical pressure in infants, with and without digestive pathology

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
0 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Weight > 4.5 kg
  • Urinary tract or bladder pathology

研究组 & 干预措施

newborn with digestive pathology

Other

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

干预措施: Measure of intravesical pressure (Other)

Newborn without digestive pathology

Other

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

干预措施: Measure of intravesical pressure (Other)

结局指标

主要结局

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

时间窗: 2 years

次要结局

  • Determine the normal intravesical pressure in critically ill children, with and without digestive pathology(2 years)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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