Evaluation of Urine Samples Obtained by Bladder Stimulation for the Diagnosis of Urinary Tract Infection in Infants

NCT03801213 | Completed

• 1 other identifier: 18-HPNCL-03
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 4

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

Conditions

Urinary Tract Infection Bacterial

Keywords

Urine Specimen Collection/methods; Infant; Newborn; Feasibility Studies; Bladder stimulation

Outcome Measures

Primary Outcomes (1)

• Bacterial contamination rates of urine samples per bladder stimulation and urinary catheterization

  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

  at 48 hours after inclusion date

Secondary Outcomes (4)

• Pain of bladder stimulation

  through intervention completion, an average 30 min

• Pain of bladder catheterization

  through intervention completion, an average 30 min

• Diagnostic performance of the dipstick urine test

  through intervention completion, an average 30 min

• Risk factors associated with the failure of the bladder stimulation technique

  through intervention completion, an average 30 min

Study Arms (2)

Urinary catheterization

ACTIVE COMPARATOR

Device: urinary catheterization

manual bladder stimulation Technique

EXPERIMENTAL

Procedure: manual bladder stimulation technique

Interventions

urinary catheterization DEVICE

Urinary catheterization with pain controlled

Urinary catheterization

manual bladder stimulation technique PROCEDURE

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

manual bladder stimulation Technique

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (4)

CH Antibes Juans les Pins

Antibes, France

Location

CH Grasse

Grasse, France

Location

CHRU Lille

Lille, France

Location

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, France

Location

Related Publications (1)

• 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.

  PMID: 31881992 DERIVED

MeSH Terms

Interventions

Urinary Catheterization

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• DEMONCHY DIANE, MD

  Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 11, 2019
• Study Start: December 12, 2019
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: February 26, 2024

Record last verified: 2023-09

Locations

FR (4)