Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants (EEStiVeN)
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|ClinicalTrials.gov Identifier: NCT03801213|
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection Bacterial||Device: urinary catheterization Procedure: manual bladder stimulation technique||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
|Active Comparator: Urinary catheterization||
Device: urinary catheterization
Urinary catheterization with pain controlled
|Experimental: manual bladder stimulation Technique||
Procedure: manual bladder stimulation technique
manual 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. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes
- Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization [ Time Frame: at 48 hours after inclusion date ]
Bacterial contamination of urine sample is defined by:
- the growth of two or more micro-organisms,
- or the presence of a non-uropathogenic germ (lactobacilli, Staphylococcus Coagulase negative, Corynebacterium),
- or a bacteriuria> 0 colony forming unit(CFU)/ml but <104 CFU / ml for bladder catheterization and <105 CFU / ml for clean catch urine collected by bladder stimulation, or leukocyturia <104 / ml
- Pain of bladder stimulation [ Time Frame: through intervention completion, an average 30 min ]pain is measured by Evaluation ENfant DOuLeur (EVENDOL) scale while the technique is performed. EVENDOL is a pain scale for children under 7. A pain scale validated for children from birth to 7 years. Score ranges from 0 to 15. Treatment threshold: 4/15.
- Pain of bladder catheterization [ Time Frame: through intervention completion, an average 30 min ]pain is measured by Evaluation ENfant DOuLeur (EVENDOL) scale while the technique is performed. EVENDOL is a pain scale for children under 7. A pain scale validated for children from birth to 7 years. Score ranges from 0 to 15. Treatment threshold: 4/15.
- Diagnostic performance of the dipstick urine test [ Time Frame: through intervention completion, an average 30 min ]
The diagnostic performance of the urinary dipstick will be established through sensitivity , specificity, positive predictive value and negative predictive value taking as Gold Standard cytobacteriological examination of the urine (ECBU). Diagnostic performance, as well as accuracy, will be established in each of the two groups.
The sensitivity and specificity will be calculated as well as their 95% confidence intervals calculated using the method of the Wilson score
- Risk factors associated with the failure of the bladder stimulation technique [ Time Frame: through intervention completion, an average 30 min ]for a urinary sample quantity < 2 ml or no urinary sample collected; potential risk factors for failure will be collected (pain, Wight, sex, age, last food and time since las collect urine)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801213
|Contact: DEMONCHY DIANE, MD||+33(0)email@example.com|
|Contact: TRAN ANTOINE, MDfirstname.lastname@example.org|
|Hôpitaux Pédiatriques de Nice CHU-Lenval||Not yet recruiting|
|Contact: Demonchy Diane|
|Principal Investigator:||DEMONCHY DIANE, MD||Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice|