Bladder Stimulation Technique for Clean Catch Urine Collection in Infants

NCT03174834 | Unknown DMC

• 1 other identifier: 1702000315
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infections

Keywords

Bladder Stimulation Technique; Clean Catch Urine; UTI in infants less than 6 months

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Time required for successful urine collection using the bladder stimulation technique

  6 Months

• Time required for successful urine collection from the start of feeding

  6 Months

• Patient distress ( parental perception ) during bladder stimulation technique

  6 Months

• Parent and provider satisfaction with bladder stimulation technique

  6 Months

• Economic impact of the bladder stimulation technique

  6 Months

Study Arms (1)

Bladder Stimulation Technique

OTHER

Single arm study, where urine collection will be done via bladder stimulation and subsequently catheterization if they meet the eligibility criteria.

Other: Bladder Stimulation technique

Interventions

Bladder Stimulation technique OTHER

The bladder stimulation technique is performed following genital cleaning with a 2% castile soap towelette, which is part of the sterile clean catch urine collection cup kit. For the technique, 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 300 seconds.

Bladder Stimulation Technique

Eligibility Criteria

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Michigan: lead
• Sarnaik Endowment Fund: collaborator
• CHMF Annual Fund: collaborator
• Blue Cross Blue Shield of Michigan Foundation: collaborator

Study Sites (1)

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 21873693 BACKGROUND

• 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.

  PMID: 18316994 BACKGROUND

• 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.

  PMID: 18192318 BACKGROUND

• 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. doi: 10.1037//0735-7044.104.1.21.

  PMID: 2317278 BACKGROUND

• Ravichandran Y, Parker S, Farooqi A, DeLaroche A. Bladder Stimulation for Clean Catch Urine Collection: Improved Parent and Provider Satisfaction. Pediatr Emerg Care. 2022 Jan 1;38(1):e29-e33. doi: 10.1097/PEC.0000000000002524.

  PMID: 34475366 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yagnaram Ravichandran, MD

  Childrens Hospital of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yagnaram Ravichandran, MD

CONTACT

3137455205; yaggudoc@gmail.com

Amy Delaroche, MD

CONTACT

3137455205; ADelaroc@dmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Pediatrics Emergency Medicine

Study Record Dates

• First Submitted: May 27, 2017
• First Posted: June 5, 2017
• Study Start: September 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)