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.
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.
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.
- Conditions
- Urinary Tract Infection
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bladder stimulation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Length of bladder stimulation time (minutes) required for successful urine collection.
Measured: 5 minutes
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
Patient distress as perceived by parent/guardian, measured using a 10 cm Visual Analog Scale (VAS).
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tighe Crombie, Children's Hospital of Eastern Ontario
- Investigators
- Tighe Crombie, MD, Principal investigator, Children's Hospital of Eastern OntarioAmy C Plint, MD, Principal investigator, Children's Hospital of Eastern OntarioRobert Slinger, MD, Principal investigator, Children's Hospital of Eastern Ontario
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Midstream Urine Collection Technique for Infants in the Emergency Department
- ClinicalTrials.gov ID
- NCT02381834
- Acronym / sponsor ID
- 14/190X
- Conditions
- Urinary Tract Infection
- Keywords
- Urine Specimen Collection, Infant, Neonate, Bacterial Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bladder stimulation technique | Experimental | Procedure: Bladder stimulation techniqueThis 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. |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder stimulation technique | Procedure or surgery | Bladder stimulation technique |
Primary outcome
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
5 secondary outcomes
Proportion of contaminated samples (contamination being defined as growth of ≥ 2 microorganisms or growth of a single type of non-uropathogenic organism)
Time frame: 24 hours
Length of bladder stimulation time (minutes) required for successful urine collection.
Time frame: 5 minutes
Length of time (minutes) required to complete the full study protocol (from initiation of feeding/IV fluid administration to completed urine collection)
Time frame: 1 hour
Patient distress as perceived by parent/guardian, measured using a 10 cm Visual Analog Scale (VAS).
Time frame: 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.
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tighe Crombie, MD principal investigator
Children's Hospital of Eastern Ontario
Amy C Plint, MD principal investigator
Children's Hospital of Eastern Ontario
Robert Slinger, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
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.