Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03801213
Status:
COMPLETED
Last Update Posted:
2024-02-26
First Post:
2019-01-08
Brief Title:
Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants
Sponsor:
Fondation Lenval
Organization:
Fondation Lenval
Study Overview
Official Title:
Evaluation of the Bladder Stimulation a Non-invasive Technique of Urine Collection in Infant Less Than 6 Months to Diagnose Urinary Tract Infection a Randomized Multicenter Study
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EEStiVeN
Brief Summary:
Urinary tract infection UTI is the most common serious bacterial infection among infants Suprapubic aspiration and bladder catheterization are considered as the gold standard by the American Academy of Pediatrics for the diagnosis yet it is painful and invasive In contrast the bladder stimulation technique has been shown to be a quick and non-invasive approach to collect urine in young infants Actually the investigators dont have data on bacterial contamination rates for clean-catch midstream urine collections using this technique
Detailed Description:
Urinary tract infection UTI is common in infants and needs to be diagnosed quickly The risk for urinary tract infection before the age of 2 years is about 1-4 in boys and 3-8 in girls A delay in diagnosis exposes to severe complications In infants the symptoms are not specific A good urinalysis quality is therefore necessary for the diagnosis of UTI Different techniques exist to collect urine samples in these children who do not control their urination yet supra pubic aspiration catheterization urine collection bag and clean catch urine The American Academy of Pediatrics AAP recommends supra pubic aspiration 1-9 bacterial contamination and urinary catheterization 8-14 contamination for collecting urine but these techniques are invasive and painful The sterile bag is a non-invasive method of urine collection with a high bacterial contamination rates 26-62 leading to unnecessary antibiotic treatment Finally clean catch urine is an accepted urine sample to diagnose UTI according to the recommendations 13-27 of bacterial contamination but this method is only possible for potty-trained children Recent studies Herreros et al Altuntas et al Tran et al have shown that bladder stimulation which consists of pubic tapping and lumbar massage would be a new effective non-invasive and safe method of collecting urine in infants
Bladder stimulation may be performed by a nurse or a physician The steps of the bladder stimulation technique are as follows a cleaning the genital area with warm water and soap b bladder stimulation technique requires the presence of 3 people infants will be held under their armpits by a parent over the bed with legs dangling in males and hips flexed in females The nurse or technician will then alternate between bladder stimulation maneuvers gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds These two stimulation maneuvers will be repeated until micturition begins or for a maximum of of 3 minutes
However the investigators do not have data on the bacterial contamination rate for urine sample using this new technique the investigators hypothesize that the bladder stimulation is a technique for obtaining urine with a contamination rate equivalent to those obtained by bladder catheterization in the diagnosis of febrile urinary tract infection in infants under 6 months of age
Bladder stimulation may be performed by a nurse or a physician The steps of the bladder stimulation technique are as follows a cleaning the genital area with warm water and soap b bladder stimulation technique requires the presence of 3 people infants will be held under their armpits by a parent over the bed with legs dangling in males and hips flexed in females The nurse or technician will then alternate between bladder stimulation maneuvers gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds These two stimulation maneuvers will be repeated until micturition begins or for a maximum of of 3 minutes
However the investigators do not have data on the bacterial contamination rate for urine sample using this new technique the investigators hypothesize that the bladder stimulation is a technique for obtaining urine with a contamination rate equivalent to those obtained by bladder catheterization in the diagnosis of febrile urinary tract infection in infants under 6 months of age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None