NCT01726166

Suprapubic Aspiration Versus Urinary Catheterization In Neonates.

A Randomized Controlled Trial: Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Children's Hospital of Eastern Ontario · Academic / Other
• Sex: All
• Age: 72 Hours – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Urinary Tract Infection

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2012-11-14
• Last updated: 2020-01-22

Locations

2 sites across 1 country: Canada