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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02749188 |
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Date of registration:
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20/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infant Who Have Not Acquired Walking
StiVeN |
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Scientific title:
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Evaluation of Bladder Stimulation as a Noninvasive Technique of Urine Collection in Infants Who Have Not Acquired Walking |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02749188 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Antoine TRAN, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fondation Lenval |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants under the age of 2 years and who have not acquired walking
- To which the investigating doctor asked the indication of a urine sample in search of
a urinary tract infection, ionic and metabolic disorder
- Do not exhibiting signs of vital distress (respiratory or circulatory or neurological)
- To which the bladder stimulation does not delay the treatment
- Obtaining the authorization of the holders of parental authority
- Affiliation to social security
- Clinical examination
Exclusion Criteria:
- Parental Refusal
- Infants> 2 years or who has walking
- Infant occurring outside the pediatric emergency timetables of care permanently
- Infant having vital signs of distress (respiratory and / or circulatory and / or
neurological)
- Infant for which the bladder stimulation could delay the management
Age minimum:
N/A
Age maximum:
24 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Urinary Retention
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Intervention(s)
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Other: Bladder stimulation
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Primary Outcome(s)
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Evaluation of bladder stimulation as a noninvasive technique of urine collection in infants who have not acquired walking
[Time Frame: During baseline at time 0]
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Secondary Outcome(s)
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Evaluation of the tolerance of the infant
[Time Frame: During baseline at time 0]
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evaluation period of urine collection
[Time Frame: During baseline at time 0]
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alternative of the urine sample
[Time Frame: During baseline after 2 attemps of bladder stimulation]
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Secondary ID(s)
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14-HPNCL-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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