Ignite Creation Date:
2024-05-06 @ 1:03 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01726166
Status:
TERMINATED
Last Update Posted:
2020-01-22
First Post:
2012-11-07
Brief Title:
Suprapubic Aspiration Versus Urinary Catheterization In Neonates
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
A Randomized Controlled Trial Suprapubic Aspiration Versus Urinary Catheterization in the Neonatal Intensive Care Unit
Status:
TERMINATED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment over 3 yrs n47 No chance to reach sample size n160
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPA
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 05 ml by SPA and that there will be no difference in associated complication rates between SPA and UC
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 05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None