Clinical trial NCT03801213: Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection Bacterial
Keywords: Urine Specimen Collection/methods
Infant
Newborn
Feasibility Studies
Bladder stimulation
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 170
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 don't 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.

Eligibility criteria: Inclusion Criteria:

* Infants under the age of 6 months
* For whom an urine sample is required for the diagnosis of a urinary tract infection as follows:

  * fever \> 39 °C without symptoms
  * fever \> 38°C and uropathy or urinary tract infection
  * fever \> 38°C and \< 3 months
  * fever \> 38 °C and \> 48h
  * fever \> 38 °C with sepsis signs
* Obtaining the authorization of the holders of parental authority
* Affiliation to French social security

Exclusion Criteria:

* Do exhibiting signs of vital distress (respiratory or circulatory or neurological)
* contraindication to bladder catheterization
* antibiotic therapy in the last 48 hours
* antibiotic prophylaxis in the last 48 hours

Primary outcomes:
measure: Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization
timeFrame: at 48 hours after inclusion date
Secondary outcomes:
measure: Pain of bladder stimulation
timeFrame: through intervention completion, an average 30 min
measure: Pain of bladder catheterization
timeFrame: through intervention completion, an average 30 min
measure: Diagnostic performance of the dipstick urine test
timeFrame: through intervention completion, an average 30 min
measure: Risk factors associated with the failure of the bladder stimulation technique
timeFrame: through intervention completion, an average 30 min
Other outcomes:
Locations:
city: Antibes
country: France
facility: CH Antibes Juans les Pins
city: Grasse
country: France
facility: CH Grasse
city: Lille
country: France
facility: CHRU Lille
city: Nice
country: France
facility: Hôpitaux Pédiatriques de Nice CHU-Lenval
Study officials:
affiliation: Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
name: DEMONCHY DIANE, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Demonchy D, Ciais C, Fontas E, Berard E, Breaud J, Rohrlich PS, Dubos F, Fortier C, Desmontils J, Herisse AL, Donzeau D, Haas H, Tran A. Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study ("EE-Sti.Ve.N"). Trials. 2019 Dec 27;20(1):783. doi: 10.1186/s13063-019-3914-2.