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Trial record 29 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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
Sponsor:
Information provided by (Responsible Party):
Fondation Lenval

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

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Bacterial Device: urinary catheterization Procedure: manual bladder stimulation technique Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


  4. 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)



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: DEMONCHY DIANE, MD +33(0)492030502 demonchy.d@pediatrie-chulenval-nice.fr
Contact: TRAN ANTOINE, MD tran.a@pediatrie-chulenval-nice.fr

Locations
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France
Hôpitaux Pédiatriques de Nice CHU-Lenval Not yet recruiting
Nice, France
Contact: Demonchy Diane         
Sponsors and Collaborators
Fondation Lenval
Investigators
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Principal Investigator: DEMONCHY DIANE, MD Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice

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Responsible Party: Fondation Lenval
ClinicalTrials.gov Identifier: NCT03801213     History of Changes
Other Study ID Numbers: 18-HPNCL-03
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondation Lenval:
Urine Specimen Collection/methods
Infant
Newborn
Feasibility Studies
Bladder stimulation

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Bacterial Infections
Urologic Diseases