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Urinary Tract InfectionNCT02381834

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

A study testing Bladder stimulation technique in people with Urinary Tract Infection, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 90 days
Conditions the study is for
Urinary Tract Infection
What is being tested?
Bladder stimulation technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteCanada
Study dates
Mar 2015to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 90 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

About this study

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.

Read the detailed description

Two persons (at least one trained nurse [RN] or physician [MD] and/or one health care aid [HCA]) will be required to perform the procedure, one of whom will also measure the time between critical steps of the protocol using a stopwatch. The technique involves a combination of fluid administration and non-invasive bladder stimulation manoeuvres that include gently finger tapping the abdomen with or without lower back massage.

The first step involves bottle or breastfeeding each infant with an amount of milk that is appropriate for its weight and age. Breastfed babies that have no history of poor feeding will be fed ad libitum. Those that feed poorly will be encouraged to supplement the feed with either expressed breast milk or formula at the discretion of the parent/guardian. Formula fed infants will receive a 10 ml feed on the first day of life, increasing by 10 ml per day of age to a maximum of 70 ml per feed. For infants greater than 7 days old, 25 ml/kg will be administered per feed. Babies that demonstrate mild clinical dehydration and/or fail attempts at oral feeding may, at the discretion of the most responsible physician (MRP), have a peripheral intravenous (IV) catheter placed and receive a fluid bolus of 0.9% normal saline up to a maximum of 10-20 ml/kg given over 20-25 minutes. Infants will not be excluded if they do not feed well.

Approximately 20 minutes after the feeding or IV fluid bolus, the infant's genitals will be cleaned in a sterile technique using 0.05% chlorhexidine. Non-pharmacological analgesia, as achieved with a soother and/or 24% sucrose will be offered to prevent or lessen crying.

The second major step of the technique involves holding the infant under the axillae with their legs dangling safely above the crib mattress. An RN or MD then begins bladder stimulation by gently finger tapping on the lower abdomen in the midline just above the pubic symphysis at a frequency of 100 taps per minute. If this step is unsuccessful after 30 seconds, the RN/MD will then stimulate the lower back in the lumbar paravertebral zone by lightly massaging the area in a circular motion using both thumbs. This too will be performed for a maximum of 30 seconds. The two stimulation manoeuvres will be repeated in succession (up to a maximum of 5 minutes, or 5 cycles) until micturition occurs and a midstream urine sample can be caught in a sterile container.

Infants who spontaneously urinate after cleaning, but prior to bladder stimulation, will have their clean catch urine sent to the lab. These cases will be considered successful "non-invasive" attempts.

Infants who fail to produce urine will have further feeding/fluid administration and bladder catheterization at the discretion of the MRP.

Being tested
Bladder stimulation technique
Keywords
Urine Specimen Collection, Infant, Neonate, Bacterial Infection
Medical subject headings
Urinary Tract Infections, Bacterial Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bladder stimulation techniqueProcedure or surgery

Study groups in NCT02381834
Study groupRoleWhat they receive
Bladder stimulation techniqueExperimentalThis 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.
Receives: Procedure: Bladder stimulation technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 5 minutes

Secondary outcomes (5)
  1. Proportion of contaminated samples (contamination being defined as growth of ≥ 2 microorganisms or growth of a single type of non-uropathogenic organism)

    Measured: 24 hours

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

    Measured: 5 minutes

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

    Measured: 1 hour

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

    Measured: 5 minutes

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

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02381834
Sponsor's protocol ID
14/190X
Status last verified
Jan 2016
First submitted
3 Mar 2015
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Bladder stimulation technique in people with Urinary Tract Infection, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.

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