EPIC: Effect of Povidone Iodine Periurethral Cleansing on Level of Contamination With Clean Catch

NCT03933436 | Completed

• 1 other identifier: FWH20190009H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to see if the use of an antiseptic preparation (povidone iodine) versus cold normal saline, will decrease rates of urine contamination during the non-invasive Quick Wee (QW) collection of pediatric urine.

Conditions

Urine Contamination

Outcome Measures

Primary Outcomes (1)

• Number of participant samples indicating urine contamination

  Binary yes/no outcome of detection of microbial markers to determine level of contamination

  24 to 48 hours

Secondary Outcomes (1)

• Number of participants who void urine

  5 minutes

Study Arms (2)

Iodine

EXPERIMENTAL

Iodine swabs.

Other: Iodine swabs.

Normal Saline

ACTIVE COMPARATOR

Saline flush.

Other: Saline flush.

Interventions

Iodine swabs. OTHER

Children will then have their periurethral region gently cleansed for ten seconds with iodine swabs.

Iodine

Saline flush. OTHER

Children will then have their periurethral region gently cleansed for ten seconds with saline flush.

Normal Saline

Eligibility Criteria

• Age: 28 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DoD children aged one month (28 days) to 12 months (365 days) (if the child was born less than 36 weeks gestation, age will be corrected)
• Precontinent (meaning that the child is unable to void on command)
• Treating clinician has determined that the child requires urine sample collection for course of treatment.

You may not qualify if:

• If the treating clinician has determined that there is a need for immediate treatment and urine sample collection via invasive method, any type of anatomical or neurologic condition that will affect the ability to void or sensation of the suprapubic area.
• Children with past hypersensitivity reactions to iodine swabs.

Sponsors & Collaborators

• Travis Callahan: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, 89191, United States

Location

Related Publications (3)

• Shaw KN, Gorelick M, McGowan KL, Yakscoe NM, Schwartz JS. Prevalence of urinary tract infection in febrile young children in the emergency department. Pediatrics. 1998 Aug;102(2):e16. doi: 10.1542/peds.102.2.e16.

  PMID: 9685461 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Urinary Tract Infection in Children: Diagnosis, Treatment and Long-term Management. London: RCOG Press; 2007 Aug. Available from http://www.ncbi.nlm.nih.gov/books/NBK50606/

  PMID: 21290637 BACKGROUND

• Practice parameter: the diagnosis, treatment, and evaluation of the initial urinary tract infection in febrile infants and young children. American Academy of Pediatrics. Committee on Quality Improvement. Subcommittee on Urinary Tract Infection. Pediatrics. 1999 Apr;103(4 Pt 1):843-52. doi: 10.1542/peds.103.4.843.

  PMID: 10103321 BACKGROUND

Study Officials

• Paul F Crawford, MD

  Mike O'Callaghan Military Medical Center, 99MDG, US Air Force

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: May 1, 2019
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)