Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children

NCT06265142 | Not Yet Recruiting

• 1 other identifier: MoH/CSR/23/26368
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Urinary tract infections (UTIs) are a common source of infection in children, accounting for a significant proportion of visits every year. Diagnosing UTIs requires obtaining a urine specimen, which can be collected using four methods: invasive techniques, such as suprapubic aspiration and urethral bladder catheterization, and noninvasive techniques, such as sterile bag and clean catch. However, catheterization can be a painful and invasive procedure, particularly in young infants who are less cooperative, and sometimes tends to be rejected by parents. Given the availability of alternative methods with comparable contamination rates, we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization, as well as secondary outcomes such as pain scores, parental satisfaction, and time required to collect urine for each technique. Methods: To achieve this, we will conduct a randomized control trial in precontinent pediatric patients. A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting. A well-designed and labeled data collection sheets will be used for data collection, and the data will be entered using EPI-data software. Statistical analysis will be performed using IBM SPSS statistics. Aim: The main aim of this study is to introduce clean catch urine (bladder massage technique) to our setting, and to compare its feasibility with the bladder catheterization which is the standard practice. Patient Population: young infants from 0 to 6 months of age Intervention: There will be two groups:

1. 1.Group A (Experimental group):Urine samples will be collected using the clean catch urine method (bladder massage technique).
2. 2.Group B (Control group): Urine samples will be collected using the standard bladder catheterization method.

Conditions

Urinary Tract Infections

Keywords

clean catch urine; bladder massage; bladder catheterization; contamination rate

Outcome Measures

Primary Outcomes (2)

• Urine culture contamination rate

  Urine culture contamination rate will be evaluated in both techniques used in the study which includes dividing the total number of contaminated urine culture sets by the total number of urine culture.

  After urine culture report (usually 2-3 days after urine collection)

• Parental satisfaction questionnaire

  Parental satisfaction with the procedure techniques (in both arms) will be evaluated by a questionnaire.

  After the procedure immediately

Secondary Outcomes (2)

• duration of the procedure

  during each procedure

• Pain score

  after the procedure immediately

Study Arms (2)

Catheterization

OTHER

Group A: is the control group, participant will undergo bladder catheterization. (The standard practice)

Procedure: Bladder catheterization

Clean Catch

EXPERIMENTAL

Group B: is the experimental group, participant will undergo clean catch urine via bladder massage technique.

Procedure: clean catch urine via bladder massage technique

Interventions

Bladder catheterization PROCEDURE

Participant will undergo the standard bladder catheterization for urine collection

Catheterization

clean catch urine via bladder massage technique PROCEDURE

Participant will undergo clean catch urine via bladder massage technique

Clean Catch

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hemodynamically stable infants.
• Require urine collection as part of their work-up in the emergency department.
• Age 0 to 6 months.

You may not qualify if:

• Parental refusal.
• Unstable hemodynamically young infants.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Related Publications (16)

• 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

• Nader, S. and Alejandro, H., 2021. Urinary tract infections in children: Epidemiology and risk factors. UpToDate, Waltham, MA, pp.1-19. (Accessed on January 01, 2023).

  BACKGROUND

• 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

• Schroeder AR, Newman TB, Wasserman RC, Finch SA, Pantell RH. Choice of urine collection methods for the diagnosis of urinary tract infection in young, febrile infants. Arch Pediatr Adolesc Med. 2005 Oct;159(10):915-22. doi: 10.1001/archpedi.159.10.915.

  PMID: 16203935 BACKGROUND

• Tosif S, Baker A, Oakley E, Donath S, Babl FE. Contamination rates of different urine collection methods for the diagnosis of urinary tract infections in young children: an observational cohort study. J Paediatr Child Health. 2012 Aug;48(8):659-64. doi: 10.1111/j.1440-1754.2012.02449.x. Epub 2012 Apr 27.

  PMID: 22537082 BACKGROUND

• Labrosse M, Levy A, Autmizguine J, Gravel J. Evaluation of a New Strategy for Clean-Catch Urine in Infants. Pediatrics. 2016 Sep;138(3):e20160573. doi: 10.1542/peds.2016-0573. Epub 2016 Aug 19.

  PMID: 27542848 BACKGROUND

• Al-Orifi F, McGillivray D, Tange S, Kramer MS. Urine culture from bag specimens in young children: are the risks too high? J Pediatr. 2000 Aug;137(2):221-6. doi: 10.1067/mpd.2000.107466.

  PMID: 10931415 BACKGROUND

• Bogie AL, Sparkman A, Anderson M, Crittenden-Byers C, Barron M. Is There a Difference in the Contamination Rates of Urine Samples Obtained by Bladder Catheterization and Clean-Catch Collection in Preschool Children? Pediatr Emerg Care. 2021 Dec 1;37(12):e788-e790. doi: 10.1097/PEC.0000000000002578.

  PMID: 34772880 BACKGROUND

• Ballouhey Q, Fourcade L, Couve-Deacon E, Cros J, Lescure V, Bahans C, Chainier D, Garnier F, Guigonis V. Urine Contamination in Nontoilet-trained and Uncircumcised Boys. Urology. 2016 Sep;95:171-4. doi: 10.1016/j.urology.2016.05.056. Epub 2016 Jun 8.

  PMID: 27289027 BACKGROUND

• Badiee Z, Sadeghnia A, Zarean N. Suprapubic Bladder Aspiration or Urethral Catheterization: Which is More Painful in Uncircumcised Male Newborns? Int J Prev Med. 2014 Sep;5(9):1125-30.

  PMID: 25317295 BACKGROUND

• Mattoo TK, Shaikh N, Nelson CP. Contemporary Management of Urinary Tract Infection in Children. Pediatrics. 2021 Feb;147(2):e2020012138. doi: 10.1542/peds.2020-012138.

  PMID: 33479164 BACKGROUND

• Pantell RH, Roberts KB, Adams WG, Dreyer BP, Kuppermann N, O'Leary ST, Okechukwu K, Woods CR Jr; SUBCOMMITTEE ON FEBRILE INFANTS. Evaluation and Management of Well-Appearing Febrile Infants 8 to 60 Days Old. Pediatrics. 2021 Aug;148(2):e2021052228. doi: 10.1542/peds.2021-052228. Epub 2021 Jul 19.

  PMID: 34281996 BACKGROUND

• National Institute for Health and Care Excellence. (2007). Urinary tract infection in under 16s: diagnosis and management. Clinical guideline.. nice. org. uk/guidance/cg54.

  BACKGROUND

• Altuntas N, Tayfur AC, Kocak M, Razi HC, Akkurt S. Midstream clean-catch urine collection in newborns: a randomized controlled study. Eur J Pediatr. 2015 May;174(5):577-82. doi: 10.1007/s00431-014-2434-z. Epub 2014 Oct 17.

  PMID: 25319844 BACKGROUND

• Herreros ML, Tagarro A, Garcia-Pose A, Sanchez A, Canete A, Gili P. Accuracy of a new clean-catch technique for diagnosis of urinary tract infection in infants younger than 90 days of age. Paediatr Child Health. 2015 Aug-Sep;20(6):e30-2.

  PMID: 26435675 BACKGROUND

• Mulcrone AE, Parikh M, Ahmad FA. Reducing infant catheterization in the emergency department through clean-catch urine collection. J Am Coll Emerg Physicians Open. 2020 Aug 17;1(6):1533-1541. doi: 10.1002/emp2.12211. eCollection 2020 Dec.

  PMID: 33392562 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Urinary Catheterization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Lubna M Al Lawati, MD

  Oman Medical Speciality Board

  STUDY DIRECTOR

Central Study Contacts

Sulayyem S Al Harsousi, MD

CONTACT

97383155; r2123@resident.omsb.org

Muna M Al Ka'abi, MD

CONTACT

91797366; r2126@resident.omsb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician who will analyze the data will be blinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patient will be assessed in triage and cases to be included in the study as per the inclusion criteria, after that patients will be randomized using computerized block randomization technique into two groups. Then, patients will be assigned to a bed, pulse oximetry to be applied, data collection sheet to be filled, confirm that infant had good feeding/ didn't pass urine over last 20 minutes and proper cleaning to be done. The next step will be, collecting urine sample according to randomization group. Group A patients (control group), urine to be collected by standardized catheterization technique while group B by standard CCU technique. Meanwhile, time of each procedure to be documented. Regarding group B , after collecting urine by CCU , we recommend to collect another sample by catheterization to guide the management and antibiotic choice.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 20, 2024
• Study Start: February 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02