Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06265142
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-11
Brief Title:
Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children
Sponsor:
Oman Medical Speciality Board
Organization:
Oman Medical Speciality Board
Study Overview
Official Title:
Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Urinary tract infections UTIs are a common source of infection in children accounting for a significant proportion of visits every year Diagnosing UTIs requires obtaining a urine specimen which can be collected using four methods invasive techniques such as suprapubic aspiration and urethral bladder catheterization and noninvasive techniques such as sterile bag and clean catch However catheterization can be a painful and invasive procedure particularly in young infants who are less cooperative and sometimes tends to be rejected by parents
Given the availability of alternative methods with comparable contamination rates we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization as well as secondary outcomes such as pain scores parental satisfaction and time required to collect urine for each technique
Methods To achieve this we will conduct a randomized control trial in precontinent pediatric patients A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting A well-designed and labeled data collection sheets will be used for data collection and the data will be entered using EPI-data software Statistical analysis will be performed using IBM SPSS statistics
Aim The main aim of this study is to introduce clean catch urine bladder massage technique to our setting and to compare its feasibility with the bladder catheterization which is the standard practice
Patient Population young infants from 0 to 6 months of age
Intervention There will be two groups
1 Group A Experimental groupUrine samples will be collected using the clean catch urine method bladder massage technique
2 Group B Control group Urine samples will be collected using the standard bladder catheterization method
Clinical Measurement All collected urine samples will be labeled and sent to the laboratory All results will be retrieved from the medical records Direct measurement will be for the duration of the procedures in both experiment and control group stopwatch will be used Pain score Neonatal Infant Pain Scale and parental satisfaction survey will be filled at the time of the procedure
Outcome Contamination rate and feasibility of both urine sampling techniques
Given the availability of alternative methods with comparable contamination rates we aim to investigate the feasibility and contamination rate of clean catch urine compared to bladder catheterization as well as secondary outcomes such as pain scores parental satisfaction and time required to collect urine for each technique
Methods To achieve this we will conduct a randomized control trial in precontinent pediatric patients A pilot study with 40 samples in each arm will be conducted since there is no prior information about contamination rates in our setting A well-designed and labeled data collection sheets will be used for data collection and the data will be entered using EPI-data software Statistical analysis will be performed using IBM SPSS statistics
Aim The main aim of this study is to introduce clean catch urine bladder massage technique to our setting and to compare its feasibility with the bladder catheterization which is the standard practice
Patient Population young infants from 0 to 6 months of age
Intervention There will be two groups
1 Group A Experimental groupUrine samples will be collected using the clean catch urine method bladder massage technique
2 Group B Control group Urine samples will be collected using the standard bladder catheterization method
Clinical Measurement All collected urine samples will be labeled and sent to the laboratory All results will be retrieved from the medical records Direct measurement will be for the duration of the procedures in both experiment and control group stopwatch will be used Pain score Neonatal Infant Pain Scale and parental satisfaction survey will be filled at the time of the procedure
Outcome Contamination rate and feasibility of both urine sampling techniques
Detailed Description:
Urinary tract infection UTI is a common source of infection in children It accounts for 5 to 14 percent of visits by children every year The overall prevalence is around 7 among different age subgroups of children Several factors affect the prevalence of UTI including age gender and circumcision status
The diagnosis of UTI requires obtaining a urine specimen from the patient Generally there are four methods used in collecting urine samples which can be categorized as invasive such as suprapubic aspiration and urethral bladder catheterization and noninvasive such as Sterile bag and clean catch
The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not In non-toilet-trained patients urethral bladder catheterization or suprapubic aspiration can be used The latter is having the least contamination rate in urine culture Clean-catch urine is commonly used for toilet-trained patients If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration
Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization According to American academy of pediatrics AAP for non-toilet trained children its advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration especially when a sample obtained using a perineal bag shows positive results on a dipstick test The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old due to false positive results that can occur in the other urine collection techniques
Urethral bladder catheterization carries a 6 to 12 percent of contamination rate In regard clean catch urine method 16 to 63 percent of the contamination rate
As outlined in the guideline in National Institute for Health and Care Excellence NICE guideline to use clean catch urine wherever possible in pediatric patients below 16 years old And to reserve bladder catheterization and suprapubic aspiration when noninvasive methods are not possible or practical
previous literature demonstrated a safe and noninvasive technique to collect midstream clean-catch urine in infants It was based on bladder stimulation and paravertebral lumbar massage This technique yielded accurate and low contamination rates for infants below 90 days old Moreover the success rate was 863 percent while the contamination rate was 5 percent The safety and efficacy of the same stimulation technique in a neonatal intensive care unit setting were described in the literature The median time to collect urine was 64 seconds The success rate is 90 percent However some literature showed a lower success rate reaching 61 percent possibly due to patients with a low oral intake that were not excluded from the study
In the effort to reduce bladder catheterization in children different techniques were introduced in the previous literature to improve the clean catch urine success rate as well as the contamination rate Bladder and lumbar paravertebral massage maneuvers are a safe time-saving technique that needs to be studied further
In our setting the recommendations from international guidelines are being followed For non-toilet trained children suspected to have UTI initial urine specimen for urine dipstick is collected by sterile bag or bladder catheterization If the result of the urine dipstick came positive then urine culture is obtained via bladder catheterization if the initial specimen collected by the sterile bag In addition we lack the statistics of urine culture contamination in our laboratories
The main aim of this study is to introduce clean catch urine bladder massage technique to our setting and to compare its feasibility with the bladder catheterization which is the standard practice
The diagnosis of UTI requires obtaining a urine specimen from the patient Generally there are four methods used in collecting urine samples which can be categorized as invasive such as suprapubic aspiration and urethral bladder catheterization and noninvasive such as Sterile bag and clean catch
The selection of the urine collection technique is mainly determined by whether the patient is toilet-trained or not In non-toilet-trained patients urethral bladder catheterization or suprapubic aspiration can be used The latter is having the least contamination rate in urine culture Clean-catch urine is commonly used for toilet-trained patients If the clinical assessment of febrile infants necessitates immediate antimicrobial therapy urine culture should be obtained either by urethral bladder catheterization or suprapubic aspiration
Previous observational studies showed approximately a 1 percent contamination rate using the suprapubic aspiration technique In a prospective study done on premature infants it was found that the suprapubic aspiration technique resulted in increased pain and a higher probability of procedural failure compared to urethral bladder catheterization According to American academy of pediatrics AAP for non-toilet trained children its advisable to gather a urine sample through methods like ureteral catheterization or suprapubic bladder aspiration especially when a sample obtained using a perineal bag shows positive results on a dipstick test The latest guideline from AAP recommends urine culture to be obtained via either SPA or bladder catheterization in pediatric patients aged between 8 to 60 days old due to false positive results that can occur in the other urine collection techniques
Urethral bladder catheterization carries a 6 to 12 percent of contamination rate In regard clean catch urine method 16 to 63 percent of the contamination rate
As outlined in the guideline in National Institute for Health and Care Excellence NICE guideline to use clean catch urine wherever possible in pediatric patients below 16 years old And to reserve bladder catheterization and suprapubic aspiration when noninvasive methods are not possible or practical
previous literature demonstrated a safe and noninvasive technique to collect midstream clean-catch urine in infants It was based on bladder stimulation and paravertebral lumbar massage This technique yielded accurate and low contamination rates for infants below 90 days old Moreover the success rate was 863 percent while the contamination rate was 5 percent The safety and efficacy of the same stimulation technique in a neonatal intensive care unit setting were described in the literature The median time to collect urine was 64 seconds The success rate is 90 percent However some literature showed a lower success rate reaching 61 percent possibly due to patients with a low oral intake that were not excluded from the study
In the effort to reduce bladder catheterization in children different techniques were introduced in the previous literature to improve the clean catch urine success rate as well as the contamination rate Bladder and lumbar paravertebral massage maneuvers are a safe time-saving technique that needs to be studied further
In our setting the recommendations from international guidelines are being followed For non-toilet trained children suspected to have UTI initial urine specimen for urine dipstick is collected by sterile bag or bladder catheterization If the result of the urine dipstick came positive then urine culture is obtained via bladder catheterization if the initial specimen collected by the sterile bag In addition we lack the statistics of urine culture contamination in our laboratories
The main aim of this study is to introduce clean catch urine bladder massage technique to our setting and to compare its feasibility with the bladder catheterization which is the standard practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None