Suprapubic Aspiration Versus Urinary Catheterization In Neonates.

NCT ID: NCT01726166

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-05-31

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.

Conditions

Neonatal Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Suprapubic Aspiration

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

Urinary Catheterization

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

-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

• 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

• 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

• Minimum Eligible Age: 72 Hours
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gregory Moore

Assistant Professor, Neonatologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gregory P Moore, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

The Ottawa Hospital - General campus

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

2011813-01H

Identifier Type: -

Identifier Source: org_study_id