Clinical trial NCT01726166: Suprapubic Aspiration Versus Urinary Catheterization In Neonates.
Official title: A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neonatal Urinary Tract Infection
Keywords: Infant
contamination rates
urinary catheterization
suprapubic aspiration
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2012-11-14
Enrollment: 49
Sex: ALL
Minimum age (years): 72
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed description: See above and other sections.

Eligibility 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

Primary outcomes:
measure: Number of contaminated urine samples per SPA and UC
timeFrame: up to 2 years
Secondary outcomes:
measure: Success rates of obtaining urine by SPA versus UC
timeFrame: up to 2 years
measure: Time to perform the respective procedures
timeFrame: up to 2 years
measure: Complication rates of SPA versus UC
timeFrame: up to 2 years
measure: Contamination rates of SPA versus UC (excluding clean catch urine)
timeFrame: up to 2 years
measure: Number of attempts per procedure
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General campus
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario; Ottawa Hospital; University of Ottawa
name: Gregory P Moore, MD
role: PRINCIPAL_INVESTIGATOR
References: