Evaluation of a Novel Midstream Urine Collection Technique for Infants in the Emergency Department

NCT02381834 | Completed

• 1 other identifier: 14/190X
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Urinalysis and urine culture are commonly employed laboratory tests in the Emergency Department (ED), particularly for the purposes of investigating febrile infants in whom bacterial etiologies must be ruled out. The standard of care for obtaining sterile urine specimens in this age group remains transurethral bladder catheterization, an invasive procedure that is painful and has the potential for causing specimen contamination and iatrogenic urinary tract infection (UTI). A recent study by Herreros Fernández et al (2013) described a novel bladder stimulation technique for newborns that facilitates midstream urine collection. The success rate for this procedure was 86.3%. It remains unknown however as to whether this technique is reproducible amongst infants who present to the ED with a potentially greater severity of illness. The primary objective of this study is to determine the success rate of this technique in children ≤ 90 days old in the ED.

Conditions

Urinary Tract Infection

Keywords

Urine Specimen Collection; Infant; Neonate; Bacterial Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of patients for whom the technique is successful for urine collection within 5 minutes (success being defined as the collection of an adequate sample volume [≥ 1 mL] for urinalysis and urine culture testing)

  5 minutes

Secondary Outcomes (5)

• Proportion of contaminated samples (contamination being defined as growth of ≥ 2 microorganisms or growth of a single type of non-uropathogenic organism)

  24 hours

• Length of bladder stimulation time (minutes) required for successful urine collection.

  5 minutes

• Length of time (minutes) required to complete the full study protocol (from initiation of feeding/IV fluid administration to completed urine collection)

  1 hour

• Patient distress as perceived by parent/guardian, measured using a 10 cm Visual Analog Scale (VAS).

  5 minutes

• Components of satisfaction relating to the procedure for the parent/guardian and the Registered Nurse (RN) or Medical Doctor (MD) performing the procedure.

  5 minutes

Study Arms (1)

Bladder stimulation technique

EXPERIMENTAL

This is a two-person technique. A health care aide or nurse (RN) begins by holding the infant under the axillae with its legs dangling. A second RN or physician then performs bladder stimulation by gentle finger tapping on the lower abdomen in the midline just above the pubic symphysis at a frequency of 100 taps/min. If this is unsuccessful after 30 seconds, lower back stimulation in the lumbar paravertebral zone is performed by light massage in a circular motion using both thumbs. This too is performed for 30 seconds maximum. These two manoeuvres are repeated in succession, for a maximum of 5 minutes total, until urination occurs. Unsuccessful attempts at midstream urine collection will be followed by further feeding/fluid administration and bladder catheterization.

Procedure: Bladder stimulation technique

Interventions

Bladder stimulation technique PROCEDURE

Bladder stimulation technique

Eligibility Criteria

• Age: Up to 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≤ 90 days
• Ped-CTAS (Canadian Pediatric Triage and Acuity Scale) Level = 2-5
• Urine specimen required for culture and/or urinalysis at the discretion of the most responsible physician (MRP) or as part of a nurse-initiated medical care directive

You may not qualify if:

• Age \> 90 days
• Ped-CTAS Level = 1 (i.e. critically ill patient)
• Moderate to severe dehydration
• Significant feeding issues (e.g. suspected pyloric stenosis)
• Burn/infection/injury over site of bladder stimulation
• Previous enrollment

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections; Bacterial Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Tighe Crombie, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Amy C Plint, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

• Robert Slinger, MD

  Children's Hospital of Eastern Ontario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

CA (1)