Neonatal Urinary Tract InfectionSPANCT01726166
Suprapubic Aspiration Versus Urinary Catheterization In Neonates.
A study testing Suprapubic Aspiration and Urinary Catheterization in people with Neonatal Urinary Tract Infection, run by Children's Hospital of Eastern Ontario at 2 sites in Canada.
Trial summary
Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up to 10%. Analysis of collected urine for the presence of bacteria or fungus is the only way to make a certain UTI diagnosis. Read more about this study
- Who is it for?
- Ages 72 hours to 12 months
- Conditions the study is for
- Neonatal Urinary Tract Infection
- What is being tested?
- Suprapubic Aspiration and Urinary Catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2013to May 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 72 hours to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -All infants who are admitted to the NICU and are not known to have the exclusion criteria listed below at the time of admission
- -All infants who are greater than 72 hours of age, who are being investigated for a possible UTI, and have been consented will be eligible for randomization
Who cannot join
- Antenatal detection or suspicion of genitourinary anomaly including: ambiguous genitalia, hypospadias, posterior urethral valve, anal atresia, exstrophy-epispadias complex, and oligohydramnios secondary to probable genitourinary anomaly(e.g. renal agenesis, multicystic kidney disease)
- Antenatal hydrops
- Antenatally detected abdominal wall defect or abdominal masses
- Antenatally detected grossly dilated bowel loops
- Congenital abdominal skin lesion over the SPA puncture site
- Oliguria (<0.5 cc/kg/hr) or anuria over the 8 hours prior to attempted urine collection
Show all 13Show fewer
- Skin infection over the SPA puncture site
- Distension or enlargement of abdominal viscera (e.g. grossly dilated loops of bowel or massive organomegaly)
- Active Necrotizing enterocolitis (Bell stage II or more)
- Uncorrected thrombocytopenia (platelets < 50 x 10 6) or bleeding diathesis
- Post-abdominal surgery
- Large inguinal hernia
- Current pre-existing indwelling catheter
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Ottawa Hospital - General campus
Ottawa, Ontario, K1H 8L6, K1H 8L6
About this study
Official title: A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.
Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up to 10%.
Analysis of collected urine for the presence of bacteria or fungus is the only way to make a certain UTI diagnosis. Sterile collection of urine can be achieved in newborn infants by urinary catheterization (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean catch' where urine is collected into a sterile bottle as the baby urinates during preparation for UC. The main advantage of SPA is that it bypasses the bacteria that normally resides in the urethral opening, thus minimizing the risk of contamination. Some studies have suggested that SPA is better than UC for collecting urine in a sterile fashion in the neonate due to the difficulty of doing sterile UC in small infants resulting in more contaminated samples (also called a false-positive urine culture); there is still no clear best choice. UC is commonly used in many Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be done by the nursing staff, and generally has a higher chance of obtaining urine. SPA is a simple and safe alternative and, although it may be more painful than UC, it is performed more quickly. The reported success rate for SPA is variable, but is greatly increased when an ultrasound confirms urine in the bladder. The question remains: what is the best method for sterile collection of urine in neonates? In this study, the investigators will try to answer this question by collecting urine from neonates using either ultrasound guided SPA or UC and then comparing the contamination rates between these two methods.
Read more
The investigators hypothesize that SPA will result in less contamination of urine samples.
The investigators also hypothesize that there will be more success in obtaining an adequate urine sample (0.5 ml) by SPA, and that there will be no difference in associated complication rates between SPA and UC.
Read the detailed description
See above and other sections.
- Conditions
- Neonatal Urinary Tract Infection
- Being tested
- Suprapubic Aspiration, Urinary Catheterization
- Keywords
- Infant, contamination rates, urinary catheterization, suprapubic aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprapubic AspirationProcedure or surgery
Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
Urinary CatheterizationProcedure or surgery
Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
| Study group | Role | What they receive |
|---|---|---|
| Suprapubic Aspiration | Active comparator | A trained physician or neonatal nurse practitioner utilizing U/S guidance at the bedside will perform the SPA. An U/S machine is readily available for use in each NICU. Receives: Procedure: Suprapubic Aspiration |
| Urinary Catheterization | Active comparator | The infants will have the procedure done by NICU nurses who have been trained in performing this procedure.
If the randomly assigned infant passes urine spontaneously during a UC attempt after complete perineal cleansing and the urine is collected as a "clean catch" sample, then this infant will be analysed in the assigned group (intention to treat). Receives: Procedure: Urinary Catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of contaminated urine samples per SPA and UC
For SPA samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or the growth of Candida species plus growth of any other microorganism.
For UC samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or any growth <10^4 colony forming unit(CFU)/ml or the growth of Candida species plus growth of any other microorganism.
The different cut-off used for contamination between UC and SPA samples stems from the fact that the UC procedure is not sterile in the neonatal population.
Note that a bacterial load of <10^3 CFU/mL (e.g. 10^1 or 10^2 CFU/mL) does not grow in the media of either laboratory where our study samples are being cultured.
Further sensitivity analyses will be performed on this outcome measure.
Measured: up to 2 years
Secondary outcomes (5)
Success rates of obtaining urine by SPA versus UC
Successful withdrawal of urine is defined as obtaining 0.5ml of urine during an attempt at SPA or UC. This is the quantity required by our laboratory for urine culture.
Measured: up to 2 years
Time to perform the respective procedures
Start time will be recorded as initiation of sterile preparation of the skin. Finish time will be recorded as removal of SPA needle or UC catheter. In the event that the catheter is to remain indwelling, finish time will be recorded as the cessation of sample collection for culture
Measured: up to 2 years
Complication rates of SPA versus UC
UC complications
- macroscopic hematuria within 48 hours after the procedure including the first void.
- urinary retention (completely dry diaper with the presence of a distended bladder based on palpation and/or percussion) within the first 4 hours after the procedure.
SPA complications
- macroscopic hematuria within 48 hours after the procedure including the first void after the procedure.
- bowel perforation defined as the aspiration of stool contents or clinical and radiographic signs present within 4-6 hrs after the procedure.
- suprapubic hematoma or abscess occurring within 1 week after the procedure
- clinical peritonitis based on the new presence of some or all of the following: fever, tachycardia, absent bowel sounds, abdominal distension, guarding, rigidity or tenderness, and vomiting occuring within 72 hours after the procedure.
Measured: up to 2 years
Contamination rates of SPA versus UC (excluding clean catch urine)
Since the investigators will collect a clean catch urine sample if the randomly assigned infant passes urine spontaneously during a UC attempt but not during SPA attempt, the investigators will compare the contamination rates per UC versus SPA with the exclusion of clean catch samples to ensure pure comparison between the two procedures.
Measured: up to 2 years
Number of attempts per procedure
For UC: each time a urinary catheter is introduced through the foreskin or the urethral meatus, this will be considered one attempt.
For SPA: each time the skin is punctured by the needle, this will be considered one attempt. This allows for an attempt to include redirection of the needle as long as it remains beneath the skin.
We will be assessing for a procedural learning curve through this outcome measure and the data recorded.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Slow recruitment over 3 yrs (n=47). No chance to reach sample size (n=\~160).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dr. Gregory Moore, Children's Hospital of Eastern Ontario
- Investigators
- Gregory P Moore, MD, Principal investigator, Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726166
- Sponsor's protocol ID
- 2011813-01H
- Acronym
- SPA
- Status last verified
- Jan 2020
- First submitted
- 7 Nov 2012
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT01726166
- Acronym / sponsor ID
- SPA / 2011813-01H
- Conditions
- Neonatal Urinary Tract Infection
- Keywords
- Infant, contamination rates, urinary catheterization, suprapubic aspiration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment over 3 yrs (n=47). No chance to reach sample size (n=\~160).
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Nov 2012 (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.
Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up to 10%.
Analysis of collected urine for the presence of bacteria or fungus is the only way to make a certain UTI diagnosis. Sterile collection of urine can be achieved in newborn infants by urinary catheterization (UC) where a catheter is passed through the urethra into the bladder, suprapubic aspiration (SPA) where a needle is inserted into the bladder through the abdominal wall, or 'clean catch' where urine is collected into a sterile bottle as the baby urinates during preparation for UC. The main advantage of SPA is that it bypasses the bacteria that normally resides in the urethral opening, thus minimizing the risk of contamination. Some studies have suggested that SPA is better than UC for collecting urine in a sterile fashion in the neonate due to the difficulty of doing sterile UC in small infants resulting in more contaminated samples (also called a false-positive urine culture); there is still no clear best choice. UC is commonly used in many Neonatal Intensive Care Units (NICU) as it is considered less invasive, can be done by the nursing staff, and generally has a higher chance of obtaining urine. SPA is a simple and safe alternative and, although it may be more painful than UC, it is performed more quickly. The reported success rate for SPA is variable, but is greatly increased when an ultrasound confirms urine in the bladder. The question remains: what is the best method for sterile collection of urine in neonates? In this study, the investigators will try to answer this question by collecting urine from neonates using either ultrasound guided SPA or UC and then comparing the contamination rates between these two methods.
The investigators hypothesize that SPA will result in less contamination of urine samples.
The investigators also hypothesize that there will be more success in obtaining an adequate urine sample (0.5 ml) by SPA, and that there will be no difference in associated complication rates between SPA and UC.
Detailed description
See above and other sections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprapubic Aspiration | Active comparator | Procedure: Suprapubic AspirationA trained physician or neonatal nurse practitioner utilizing U/S guidance at the bedside will perform the SPA. An U/S machine is readily available for use in each NICU. |
| Urinary Catheterization | Active comparator | Procedure: Urinary CatheterizationThe infants will have the procedure done by NICU nurses who have been trained in performing this procedure. If the randomly assigned infant passes urine spontaneously during a UC attempt after complete perineal cleansing and the urine is collected as a "clean catch" sample, then this infant will be analysed in the assigned group (intention to treat). |
Who may qualify
- Ages
- 72 hours to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- -All infants who are admitted to the NICU and are not known to have the exclusion criteria listed below at the time of admission
- -All infants who are greater than 72 hours of age, who are being investigated for a possible UTI, and have been consented will be eligible for randomization
Key exclusion criteria (13 listed)
- Antenatal detection or suspicion of genitourinary anomaly including: ambiguous genitalia, hypospadias, posterior urethral valve, anal atresia, exstrophy-epispadias complex, and oligohydramnios secondary to probable genitourinary anomaly(e.g. renal agenesis, multicystic kidney disease)
- Antenatal hydrops
- Antenatally detected abdominal wall defect or abdominal masses
- Antenatally detected grossly dilated bowel loops
- Congenital abdominal skin lesion over the SPA puncture site
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 |
|---|---|---|
| Suprapubic AspirationPain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution. | Procedure or surgery | Suprapubic Aspiration |
| Urinary CatheterizationPain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution. | Procedure or surgery | Urinary Catheterization |
Primary outcome
Number of contaminated urine samples per SPA and UC
Time frame: up to 2 years
For SPA samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or the growth of Candida species plus growth of any other microorganism. For UC samples, urine contamination will be defined as the growth of two or more micro-organisms (any number of colonies per each microorganism) or any growth <10^4 colony forming unit(CFU)/ml or the growth of Candida species plus growth of any other microorganism. The different cut-off used for contamination between UC and SPA samples stems from the fact that the UC procedure is not sterile in the neonatal population. Note that a bacterial load of <10^3 CFU/mL (e.g. 10^1 or 10^2 CFU/mL) does not grow in the media of either laboratory where our study samples are being cultured. Further sensitivity analyses will be performed on this outcome measure.
5 secondary outcomes
Success rates of obtaining urine by SPA versus UC
Time frame: up to 2 years
Time to perform the respective procedures
Time frame: up to 2 years
Complication rates of SPA versus UC
Time frame: up to 2 years
Contamination rates of SPA versus UC (excluding clean catch urine)
Time frame: up to 2 years
Number of attempts per procedure
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: Slow recruitment over 3 yrs (n=47). No chance to reach sample size (n=\~160).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Gregory P Moore, MD principal investigator
Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprapubic Aspiration and Urinary Catheterization in people with Neonatal Urinary Tract Infection, run by Children's Hospital of Eastern Ontario at 2 sites 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 2 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Slow recruitment over 3 yrs (n=47). No chance to reach sample size (n=\~160).). Results are not available in the source record.
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?
Number of contaminated urine samples per SPA and UC (time frame: up to 2 years). 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 22 Jan 2020.