Urinary Tract Infections Clinical Trial
Official title:
Bladder Stimulation Technique for Clean Catch Urine Collection in Infants : Assessing Impact on Patients and Providers in a Pediatric Emergency Department
Urinary tract infection is the most common serious bacterial infection among infants. Bladder catheterization is considered the gold standard for diagnosis, yet is painful and invasive. In contrast, the bladder stimulation technique has been shown to be a quick and non-invasive approach to collecting urine in young infants with a contamination rate similar to bladder catheterization. Previous research, however, relied upon trained study personnel thereby limiting the generalizability of their findings. By training staff in the pediatric emergency department, this study aims to evaluate the feasibility of incorporating this technique into routine clinical practice while also assessing its impact on parent and provider satisfaction.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Months |
Eligibility |
Inclusion Criteria: - Infants less than 6 months of age who require a urine sample for urinalysis and culture as part of their PED visit (as determined by the treating physician) are eligible for inclusion Exclusion Criteria: - Parents / caregivers do not speak English - Parents / guardian unavailable to sign consent - Evidence of injury / infection to the abdomen / back precluding completion of the bladder stimulation technique - Known medical condition rendering it impossible to obtain a sample using the stimulation technique (e.g. urostomy) - Critical illness and/or hemodynamic instability - Current antibiotic therapy or antibiotics within 14 days of enrollment - Previous enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Michigan | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Michigan | Blue Cross Blue Shield of Michigan Foundation, CHMF Annual Fund, Sarnaik Endowment Fund |
United States,
Davies P, Greenwood R, Benger J. Randomised trial of a vibrating bladder stimulator--the time to pee study. Arch Dis Child. 2008 May;93(5):423-4. doi: 10.1136/adc.2007.116160. Epub 2008 Jan 11. — View Citation
Shaikh N, Morone NE, Bost JE, Farrell MH. Prevalence of urinary tract infection in childhood: a meta-analysis. Pediatr Infect Dis J. 2008 Apr;27(4):302-8. doi: 10.1097/INF.0b013e31815e4122. — View Citation
Subcommittee on Urinary Tract Infection, Steering Committee on Quality Improvement and Management, Roberts KB. Urinary tract infection: clinical practice guideline for the diagnosis and management of the initial UTI in febrile infants and children 2 to 24 months. Pediatrics. 2011 Sep;128(3):595-610. doi: 10.1542/peds.2011-1330. Epub 2011 Aug 28. — View Citation
Weisz DJ, McInerney J. An associative process maintains reflex facilitation of the unconditioned nictitating membrane response during the early stages of training. Behav Neurosci. 1990 Feb;104(1):21-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients for whom urine collection is successful using the bladder stimulation technique | The technique will be performed following genital cleaning. Infants will be held under their armpits by a parent over the bed, with legs dangling in males and hips flexed in females followed by 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 300 seconds. Urine will be collected in a clean catch specimen container. The research assistant will time the procedure from the start of the stimulation techniques to the start of micturition using a stopwatch. Non nutritive sucking on a pacifier with/without sucrose will be provided as an optional comfort measure. A successful urine collection using the bladder stimulation techniques will be defined by onset of micturition within 300 seconds of bladder stimulation. | 6 Months | |
Primary | Proportion of bacterial contamination among samples collected using the bladder stimulation technique | Contamination rates of urine cultures obtained using the bladder stimulation technique will be expressed in terms of proportion to the total sample size and this rate will be compared to the contamination rates of urine cultures obtained via catheterization. The criteria for contamination will be determined per the AAP guidelines for positive urine culture versus contamination rates. Laboratory definitions of a positive urinalysis and urine culture are defined based on definitions published by the American Academy of Pediatrics and previous authors investigating the bladder stimulation technique. Three criteria are needed for each definition: Urinalysis result, number of organisms cultured and specific threshold for colony counts based on method of collection. Positive urinalysis: Bacteriuria, positive leukocyte esterase test, positive nitrite test and/or >/= 10 white blood cells per micro liter; negative urinalysis: do not meet criteria for positive urinalysis |
6 months | |
Secondary | Time required for successful urine collection using the bladder stimulation technique | The investigators aim to evaluate the time required for successful urine collection using the bladder stimulation technique. The research assistant will time the procedure from the start of the stimulation techniques to the start of micturition using a stopwatch. The timing will start from the time the bladder stimulation maneuvers start after the patient is positioned and cleaned till the onset of micturition or until 300 seconds, whichever is earlier. The investigators aim to assess the time taken for successful urine collection using bladder stimulation, especially since prior studies have reported onset of urination within 57 seconds. the ultimate goal is to show that this method of collection is easy, minimally invasive and quick. |
6 Months | |
Secondary | Time required for successful urine collection from the start of feeding | The investigators also aim to evaluate the time required for successful urine collection for the entire bladder stimulation technique (initiation of feeding to start of voiding). The research associate will retrospectively review charts and look at the time feeding was initiated and the time taken till the onset of micturition. By doing this, the investigators aim to evaluate the total time of the procedure and thereby establish this as a potentially rapid and quick procedure as compared to catheterization with potential impact on the length of stay. | 6 Months | |
Secondary | Patient distress ( parental perception ) during bladder stimulation technique | The investigators aim to evaluate patient distress during the bladder stimulation technique using the Numeric Rating Scale (NRS). During the bladder stimulation technique, parental perception of pain will be assessed using the Numeric Rating Scale (NRS). The research assistant will administer the NRS to the parent immediately prior to the procedure (T0), during the bladder stimulation technique (T1), 1 minute after completion of the bladder stimulation technique (T2) and 5 minutes after completion of the bladder stimulation technique (T3). For infants undergoing catheterization, parental perception of pain will also be assessed using the NRS at similar time intervals. |
6 Months | |
Secondary | Parent and provider satisfaction with bladder stimulation technique | The investigators aim to evaluate parent and provider satisfaction with urine collection using the bladder stimulation technique. After collection of the urine sample using the stimulation technique (whether successful or not), the parent and the nurse will complete a brief questionnaire (administered by the research assistant). The parent questionnaire aims to evaluate parental perception of discomfort and their satisfaction with the stimulation technique. The provider questionnaire evaluates their comfort with the procedure and their perception of patient discomfort. Similar questionnaires will be distributed to the parent and the nurse following catheterization when this procedure is performed. |
6 Months | |
Secondary | Economic impact of the bladder stimulation technique | The investigators aim to evaluate the economic impact of the bladder stimulation technique. The cost of the bladder stimulation technique will be based on cost of the urine collection cup and nursing time spent on the maneuver. This will be compared to the cost of a urine catheterization kit. Ultimate aim is to evaluate and establish bladder stimulation clean catch as a more cost effect method compared to catheterization. |
6 Months |
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