Suprapubic Aspiration Versus Urinary Catheterization In Neonates.

NCT01726166 | Terminated

• 1 other identifier: 2011813-01H
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Neonatal Urinary Tract Infection

Keywords

Infant; contamination rates; urinary catheterization; suprapubic aspiration

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years

Secondary Outcomes (5)

• Success rates of obtaining urine by SPA versus UC

  up to 2 years

• Time to perform the respective procedures

  up to 2 years

• Complication rates of SPA versus UC

  up to 2 years

• Contamination rates of SPA versus UC (excluding clean catch urine)

  up to 2 years

• Number of attempts per procedure

  up to 2 years

Study Arms (2)

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.

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).

Procedure: Urinary Catheterization

Interventions

Suprapubic Aspiration PROCEDURE

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.

Suprapubic Aspiration

Urinary Catheterization PROCEDURE

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 Catheterization

Eligibility Criteria

• Age: 72 Hours - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (2)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Ottawa Hospital - General campus

Ottawa, Ontario, K1H 8L6, K1H 8L6, Canada

Location

MeSH Terms

Interventions

Urinary Catheterization

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Urological; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• Gregory P Moore, MD

  Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Neonatologist

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 14, 2012
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)