Ignite Creation Date:
2024-05-06 @ 5:45 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05416736
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2022-06-09
Brief Title:
The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns
Sponsor:
Istanbul University - Cerrahpasa IUC
Organization:
Istanbul University - Cerrahpasa IUC
Study Overview
Official Title:
The Effect of Bladder Stimulation Technique on Urine Specimen Collection in Newborns A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Urine specimen are necessary to diagnose various diseases in infants especially urinary tract infections UTI Various non-invasive and invasive clinical interventions have been described for urine specimen collection These suprapubic aspiration urinary catheterization sterile urine collection bag and clean-caught urine Herreros Fernández et al 2013 For the diagnosis of UTI it is recommended to collect urine samples by suprapubic aspiration SPA and urinary catheterization methods However these techniques are invasive and painful Roberts et al 2016 Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI But this method is possible for children with sphincter control A technique was recently described that allows midstream urine specimen collection in children without sphincter control This technique consists of bladder stimulation and lumbar paravertebral massage The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success procedure time physiological parameters and comfort in urine specimen collection in newborns
Detailed Description:
Urinary Tract Infection UTI is common in early childhood Urinary Tract Infection UTI is the most common bacterial infection in febrile children younger than 3 months of age Korbel et al 2017 Velasco et al 2015 A clean urine sample is required to diagnose various diseases especially urinary tract infections UTI in infants Various non-invasive and invasive clinical interventions have been described for urine specimen collection These suprapubic aspiration urinary catheterization sterile urine collection bag and clean-caught urine Herreros Fernández et al 2013
One of the non-invasive methods used to collect urine samples is the use of sterile urine collection bags Herreros Fernández et al 2013 This method is not an effective method due to its high false positive rate time consuming delayed treatment skin irritation and high risk of contamination Finnell et al 2011 Kaufman et al 2020 Therefore sterile urine bags should be used in urinalysis instead of urine culture Balighian Review 2018 Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI However this method is possible for children with sphincter control Altuntas et al 2015 Kaufman et al 2019
A technique was recently described that allows midstream urine specimen collection in children without sphincter control The technique consisting of bladder stimulation and lumbar paravertebral massage was successful in 86 of newborns with an average duration of 57 seconds Herreros Fernández et al 2013 Previous studies have evaluated the techniques success rate and processing time Altuntas et al 2015 Labrosse et al 2016 Crombie et al 2020 contamination rate Herreros et al 2021 and cost Kaufman et al 2020 examined Examination of the effect of the technique on the comfort and physiological parameters of the newborn will contribute to more information about the technique
The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success procedure time physiological parameters and comfort in urine specimen collection in newborns
Study Population and Sampling The population of the research will be the newborns followed in the neonatal intensive care unit The sample will consist of 64 Experimental group 32 Control group 32 newborns who meet the inclusion criteria of the study In calculating the sample size Altuntaş et al 2015 benefited from the study Considering the success rates The minimum number of samples to be taken was determined as 64 Experimental group32 Control group32 with 95 confidence 1-α 95 test power 1-β w0453 effect size
Randomization Infants meeting the research inclusion criteria will be divided into experimental and control groups using a computer-based program httpswwwrandomizerorg
Data Collection Method The data will be collected by the a researcher in the unit where the study is planned to be carried out
Data Collection Form Prepared by the researcher The form includes questions about the infants age weight gender fever heartbeat saturation level Comfortneo scale score and procedure success and duration of the procedure
Comfortneo scale Developed by Ambuel et al Ambuel etal 1992 Van Dijk et al revised the COMFORTneo scale to measure behavior in newborns without physiological parameters Van Dijk et al 2009 Turkish validity and reliability of the scale Kahraman et al Kahraman et al 2014 The scale consists of 7 items muscle tone alertness facial tension calmnessagitation body movements respiratory response and crying Respiratory response is scored in infants on mechanical ventilator and crying is scored in spontaneously breathing infants A total score is calculated over 6 items The lowest score that can be obtained from this scale is 6 and the highest score is 30 A high score indicates that the baby is not comfortable and needs interventions to provide comfort Kahraman et al 2014
Pulse Oximeter Device to detect infants oxygen saturation SPO2 and heart rate HR
Weighing Tool to determine the current weight of babies
Thermometer to determine babies body temperature
One of the non-invasive methods used to collect urine samples is the use of sterile urine collection bags Herreros Fernández et al 2013 This method is not an effective method due to its high false positive rate time consuming delayed treatment skin irritation and high risk of contamination Finnell et al 2011 Kaufman et al 2020 Therefore sterile urine bags should be used in urinalysis instead of urine culture Balighian Review 2018 Clean-caught urine provides an acceptable urine sample for the diagnosis of UTI However this method is possible for children with sphincter control Altuntas et al 2015 Kaufman et al 2019
A technique was recently described that allows midstream urine specimen collection in children without sphincter control The technique consisting of bladder stimulation and lumbar paravertebral massage was successful in 86 of newborns with an average duration of 57 seconds Herreros Fernández et al 2013 Previous studies have evaluated the techniques success rate and processing time Altuntas et al 2015 Labrosse et al 2016 Crombie et al 2020 contamination rate Herreros et al 2021 and cost Kaufman et al 2020 examined Examination of the effect of the technique on the comfort and physiological parameters of the newborn will contribute to more information about the technique
The aim of this study is to evaluate the effect of bladder stimulation technique on procedural success procedure time physiological parameters and comfort in urine specimen collection in newborns
Study Population and Sampling The population of the research will be the newborns followed in the neonatal intensive care unit The sample will consist of 64 Experimental group 32 Control group 32 newborns who meet the inclusion criteria of the study In calculating the sample size Altuntaş et al 2015 benefited from the study Considering the success rates The minimum number of samples to be taken was determined as 64 Experimental group32 Control group32 with 95 confidence 1-α 95 test power 1-β w0453 effect size
Randomization Infants meeting the research inclusion criteria will be divided into experimental and control groups using a computer-based program httpswwwrandomizerorg
Data Collection Method The data will be collected by the a researcher in the unit where the study is planned to be carried out
Data Collection Form Prepared by the researcher The form includes questions about the infants age weight gender fever heartbeat saturation level Comfortneo scale score and procedure success and duration of the procedure
Comfortneo scale Developed by Ambuel et al Ambuel etal 1992 Van Dijk et al revised the COMFORTneo scale to measure behavior in newborns without physiological parameters Van Dijk et al 2009 Turkish validity and reliability of the scale Kahraman et al Kahraman et al 2014 The scale consists of 7 items muscle tone alertness facial tension calmnessagitation body movements respiratory response and crying Respiratory response is scored in infants on mechanical ventilator and crying is scored in spontaneously breathing infants A total score is calculated over 6 items The lowest score that can be obtained from this scale is 6 and the highest score is 30 A high score indicates that the baby is not comfortable and needs interventions to provide comfort Kahraman et al 2014
Pulse Oximeter Device to detect infants oxygen saturation SPO2 and heart rate HR
Weighing Tool to determine the current weight of babies
Thermometer to determine babies body temperature
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