- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726166
Suprapubic Aspiration Versus Urinary Catheterization In Neonates. (SPA)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
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Ottawa, Ontario, Canada, K1H 8L6, K1H 8L6
- The Ottawa Hospital - General Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria (to be approached for consent):
-All infants who are admitted to the NICU and are not known to have the exclusion criteria listed below at the time of admission
Exclusion criteria (to be approached for consent):
- 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
Inclusion criteria (prior to randomization):
-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
Exclusion criteria (prior to randomization):
- Oliguria (<0.5 cc/kg/hr) or anuria over the 8 hours prior to attempted urine collection
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Suprapubic Aspiration
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.
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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.
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Active Comparator: Urinary Catheterization
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). |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of contaminated urine samples per SPA and UC
Time Frame: up to 2 years
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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. |
up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rates of obtaining urine by SPA versus UC
Time Frame: up to 2 years
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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.
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up to 2 years
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Time to perform the respective procedures
Time Frame: up to 2 years
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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
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up to 2 years
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Complication rates of SPA versus UC
Time Frame: up to 2 years
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UC complications
SPA complications
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up to 2 years
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Contamination rates of SPA versus UC (excluding clean catch urine)
Time Frame: up to 2 years
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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.
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up to 2 years
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Number of attempts per procedure
Time Frame: up to 2 years
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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. |
up to 2 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gregory P Moore, MD, Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011813-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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