Suprapubic Aspiration Versus Urinary Catheterization In Neonates. (SPA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Hospital of Eastern Ontario
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Gregory Moore, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT01726166
First received: November 7, 2012
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

Urinary tract infection (UTI) is relatively common in infants, with an occurence rate of up to 10%. It is more frequent in male and preterm newborn infants and can lead to significant problems in infants including blood infections, kidney infections, and kidney scarring which can affect how the kidneys work later in life.

Analysis of collected urine for the presence of bacteria or fungus is the only way to make a certain UTI diagnosis. Urine culture results may take 24 to 48 hours to become available. 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 are some problems with the way these studies were done so 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 some studies suggest that it is more painful than UC, it it performed more quickly. The reported success rate for SPA is variable, but is greatly increased when an ultrasound confirms urine in the bladder before doing the SPA. The question remains: what is the best method for sterile collection of urine in newborns and young infants? In this study, the investigators will try to answer this question by collecting urine from infants admitted to our NICU 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, SPA will be quicker to perform, and that there will be no difference in associated complication rates between SPA and UC.


Condition Intervention
Neonatal Urinary Tract Infection
Procedure: Suprapubic Aspiration
Procedure: Urinary Catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Number of contaminated urine samples per SPA and UC [ Time Frame: April 2013 - March 2015 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Success rates of obtaining urine by SPA versus UC [ Time Frame: April 2013 - March 2015 ] [ Designated as safety issue: No ]
    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.

  • Time to perform the respective procedures [ Time Frame: April 2013 - March 2015 ] [ Designated as safety issue: No ]
    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

  • Complication rates of SPA versus UC [ Time Frame: April 2013 - March 2015 ] [ Designated as safety issue: Yes ]

    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.

  • Contamination rates of SPA versus UC (excluding clean catch urine) [ Time Frame: April 2013 - March 2015 ] [ Designated as safety issue: No ]
    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.

  • Number of attempts per procedure [ Time Frame: April 2013 - May 2015 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 165
Study Start Date: April 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Suprapubic Aspiration
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.
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).

Procedure: Urinary Catheterization
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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726166

Contacts
Contact: Gregory P Moore, MD 613-737-8899 ext 78909 gmoore@cheo.on.ca

Locations
Canada, Ontario
The Ottawa Hospital - General campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6, K1H 8L6
Contact: Lynne Cullen, RN, CRC    613-737-7600 ext 3782    lcullen@cheo.on.ca   
Contact: Samantha Somers, BA    613-737-7600 ext 2794    ssomers@cheo.on.ca   
Principal Investigator: Gregory P Moore, MD         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Lynne Cullen, RN, CRC    613-737-7600 ext 3782    lcullen@cheo.on.ca   
Contact: Samantha Somers, BA    613-737-7600 ext 2794    ssomers@cheo.on.ca   
Principal Investigator: Gregory P Moore, MD         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Gregory P Moore, MD Children's Hospital of Eastern Ontario; The Ottawa Hospital; The University of Ottawa
  More Information

No publications provided

Responsible Party: Dr. Gregory Moore, Assistant Professor, Neonatologist, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01726166     History of Changes
Other Study ID Numbers: 2011813-01H
Study First Received: November 7, 2012
Last Updated: July 3, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:
Infant
contamination rates
urinary catheterization
suprapubic aspiration

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014