Suprapubic Aspiration Versus Urinary Catheterization In Neonates. (SPA)

Children's Hospital of Eastern Ontario

Status: Terminated

Conditions: Neonatal Urinary Tract Infection

Treatments: Procedure: Suprapubic Aspiration; Procedure: Urinary Catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT01726166

2011813-01H

Details and patient eligibility

About

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.

Full description

See above and other sections.

Enrollment: 49 patients

Sex: All

Ages: 72 hours to 12 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Suprapubic Aspiration

Active Comparator group

Description:

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.

Treatment:

Procedure: Suprapubic Aspiration

Urinary Catheterization

Active Comparator group

Description:

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).

Treatment:

Procedure: Urinary Catheterization