Clean Catch Urine Feasibility and Contamination Rate Compared to Bladder Catheterization Urine in Pre-Continent Children: Randomized Control Trial
Phase: NA
Conditions: Urinary Tract Infections
Sponsor: Oman Medical Speciality Board

Clinical study protocol 
 
 
 
 
Document date: January 1, 2024 
 
 
 
 
Clean Catch Urine Feasibility and 
Contamination Rate compared to Bladder 
Catheterization Urine in Pre-Continent 
Children: Randomized Control Trial 
 
 
 
 
Prospective, randomized controlled trial, pilot, multicentered, non-inferiority, 
comparing contamination rate between clean catch urine and bladder 
catheterization. 
 
 

Table of Contents 
1. 
Research Proposal Cover Page: ........................................................................................... 3 
2. 
Summary: .............................................................................................................................. 5 
3. 
Introduction: literature review and justification of the study. ............................................ 7 
4. 
Objectives and hypothesis of the study: ............................................................................... 9 
5. 
Feasibility of the study .......................................................................................................... 9 
6. 
Research Design and Methods ............................................................................................. 9 
7. 
Randomization .................................................................................................................... 10 
8. 
Study flow ............................................................................................................................ 10 
9. 
Study procedures ................................................................................................................. 11 
10. 
Variable definitions and measurements ............................................................................ 11 
11. 
Ethical considerations ........................................................................................................ 11 
12. 
Conflict of interest .............................................................................................................. 11 
13. 
Incentives ............................................................................................................................ 11 
14. 
Results Dissemination ........................................................................................................ 11 
15. 
Management and monitoring of the research activities .................................................... 12 
16. 
Limitations and difficulties of the study: ........................................................................... 12 
17. 
Rationale for subject selection and recruitment. ............................................................... 12 
18. 
Statistical analysis: ............................................................................................................. 12 
19. 
Criteria for terminating the study. ..................................................................................... 13 
20. 
Quality control and quality assurance. .............................................................................. 13 
21. 
Data handling and record keeping..................................................................................... 13 
22. 
Procedures for reporting deviations from the original plan. ............................................ 14 
23. 
Anticipated results .............................................................................................................. 14 
24. 
References: .......................................................................................................................... 14 
25. 
Appendix ............................................................................................................................. 16 
 
 
 
 

1. Research Proposal Cover Page:  
 
Project details 
Date: 
15/01/2024 
Project title: 
Clean Catch Urine Feasibility and 
Contamination Rate compared to 
Bladder Catheterization Urine in Pre-
Continent Children: Randomized 
Control Trial 
Study design: 
Randomized controlled trial. Pilot 
study 
Study clinical site: 
Pediatric emergency departments at 
Royal hospital and An Nahdha 
hospital, located in Muscat, Sultanate 
of Oman. 
Principal investigator: 
Title and Name: 
 Dr. Sulayyem Saleh Al Harsousi 
Staff ID: 
80469 
Job Title: 
MD, Emergency medicine resident 
Email: 
alharsoosi@gmail.com 
Phone 
(+968) 97383155 
Co-investigator: 
Title and Name: 
 Dr. Muna Mohammed 'Obaid Al 
Ka'abi 
Staff ID: 
80501 
Job Title: 
MD, Emergency medicine resident 
Email: 
r2126@resident.omsb.org 
Phone 
(+968) 91797366 
Co-investigator: 
Title and Name: 
Dr. Lubna Mohsin Juma Al Lawati 
Staff ID: 
32780 
Job Title: 
MD, OMSB, DESC (French Board), 
CEDE (Certified ED Executive). 
Pediatric emergency consultant.  
Email: 
Lubna.allawati@gmail.com 
Phone 
(+968) 99466499 
Co-investigator: 
Title and Name: 
Dr. Saif Hamed Khalfan Al Ghafri 
Staff ID: 
56376 

Job Title: 
MD, FRCPc, Fellow in ICU and Sports 
Medicine. Emergency medicine 
consultant. 
Email: 
saifalghafri1@gmail.com 
Phone 
(+968) 99814471 
Co-investigator: 
Title and Name: 
Dr. Aisha Salim Hamood Al Shuaibi 
Staff ID: 
80828 
Job Title: 
Pediatric specialist, OMSB 
Email: 
Shoaibi2012@gmail.com 
Phone 
(+968) 989193733 
 
 
 

2. 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 group):Urine 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 
 
 
 

3. Introduction: literature review and justification of the study. 
 
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 [1]. 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 
[2]. 
 
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) [3]. 
 
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 [3]. 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 [3, 4]. 
 
Previous observational studies showed approximately a 1 percent contamination 
rate using the suprapubic aspiration technique [5,6,7,8,9]. 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 [10]. According to American academy of 
pediatrics (AAP), for non-toilet trained children, it's 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 [11]. 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 [12]. 
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 [2].  
 
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 [13]. 

 
Herreros et al. demonstrated a safe and noninvasive technique to collect midstream 
clean-catch urine in infants. It was based on bladder stimulation and paravertebral 
lumbar massage [14]. This technique yielded accurate and low contamination rates 
for infants below 90 days old. Moreover, the success rate was 86.3 percent, while 
the contamination rate was 5 percent. Nilgun et al. emphasized the safety and 
efficacy of the same stimulation technique in a neonatal intensive care unit setting. 
The median time to collect urine was 64 seconds. The success rate is 90 percent. 
However, Labrosse et al. showed a lower success rate reaching 61 percent, 
possibly due to patients with a low oral intake that were not excluded from the 
study [6,15]. 
 
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 [6,14,15,16]. Bladder and lumbar paravertebral 
massage maneuvers as described by Herreros et al 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.  
 
 

4. Objectives and hypothesis of the study: 
 
Primary outcome: 
To compare the contamination rates between the two method and parent 
satisfaction.  
Secondary outcome: 
To compare procedure duration in both methods. And pain score (using neonatal 
infant pain scale) 
 
Study hypothesis  
 
• The contamination rate of clean catch urine sampling is similar to the bladder 
catheterization.  
• Less painful as it is less invasive.  
 
 
5. Feasibility of the study 
It is a multicentered study which enrolls pediatric patients who need urine 
collection according to the mentioned inclusion criteria. Notably, urinary tract 
infection (UTI) is a very common presentation in this age group, and it should be 
considered in almost all pediatric patients with fever with no clear source of 
infection. All the previously mentioned points can assure that the targeted sample 
size can be achieved within the designated timeline.  
6. Research Design and Methods 
 
Study design:  
 
This pilot study will be conducted as randomized controlled trial.  
 
Characteristics of study area and target population: 
Study will be conducted in a tertiary hospital, pediatric emergency, and pediatric 
ward. Target population are pediatric patients aged between 0 to 6 months. 
 
 
Primary and secondary endpoints: 
Primary endpoints: Urine culture contamination rate and parental satisfaction 
Secondary endpoints: Pain score (utilizing Neonatal Infant Pain Scale) and 
duration of the procedures.  

 
Selection and withdrawal of subjects:  
All infants younger than 6 months of age, who require urine sample as part fever 
work-up in emergency department.  
Any subject may be withdrawn from the study at any time for any reason and 
without penalty or prejudice. 
 
Sampling and sample size: 
A pilot study with 40 samples in each arm will be conducted since there is no prior 
information about contamination rates in our local setting. 
7. Randomization 
The study will utilize computerized block randomization technique to assign 
participants into experimental and control groups, with each block being 
randomized to ensure unbiased allocation. The randomization will occur in the 
emergency triage.  
8. Study flow 
Patient will be assessed in triage and cases to be included in the study as per the 
inclusion criteria, after that patients will be randomized using computerized block 
randomization technique into two groups. Then, patients will be assigned to a bed, 
pulse oximetry to be applied, data collection sheet to be filled, confirm that infant 
had good feeding/ didn’t pass urine over last 20 minutes and proper cleaning to be 
done. The next step will be, collecting urine sample according to randomization 
group. Group A patients (control group), urine to be collected by standardized 
catheterization technique while group B by standard CCU technique. Meanwhile, 
time of each procedure to be documented. Regarding group B , after collecting 
urine by CCU , we recommend to collect another sample by catheterization to 
guide the management and antibiotic choice. (Appendix: Study flow chart ) 
 
 

9. Study procedures 
Clean catch urine (bladder massage technique) provided in the appendix.  
10. Variable definitions and measurements 
 
 
Data collection tools and methods: (provided in the appendix) 
Data quality: 
In each site there will be a focal point doctor, responsible for the site. Before 
conducting the study, we will do training sessions about the study and we will 
prepare a video teaching the physicians/ nurses the steps of urine collection of by 
clean catch technique. Individual meetings to be conducted with the focal point for 
each site to clarify their inquiry. We will use a research assistant for data collection 
to facilitate the process and to help monitoring the flow of the study protocol. 
 
Data analysis: We will use Statistical Package for the Social Sciences (SPSS) 
applications version 25 for our analysis. 
 
11. Ethical considerations 
Already we have the ethical approval from the ministry of health of Oman 
(proposal ID: MoH/CSR/23/26368), all recommended changes were adjusted 
before starting the study. If any risk on patient safety noticed during our study, we 
will make sure to stop the study protocol. We are not anticipating any harm to 
patient as the technique our study introducing is less invasive and more 
comfortable to patients. For the patient group with CCU collection, we are 
recommending another sample of urine to be collected to guide the antibiotics 
choice as CCU contamination rate and accuracy will be studied by this paper. 
12. Conflict of interest 
 
No conflict of interest 
13. Incentives 
No incentives of any kind will be given to the participants.  
14. Results Dissemination 
The study results will be disseminated through various channels to ensure wider 
reach and maximum impact. This includes local and international publication of the 

study in peer-reviewed journals, as well as presentation of findings at relevant 
conferences and symposiums. Additionally, we plan to share the study outcomes 
with relevant stakeholders such as healthcare professionals, policymakers to ensure 
that the findings are effectively translated into practice and policy. 
 
15. Management and monitoring of the research activities 
Each focal point will be responsible for that hospital work flow. As each focal 
point will be in direct contact with the workers at the specific site. Daily monitor to 
be done to check the new enrolled cases. The other researchers to follow the whole 
workflow weakly by contact the assigned focal point. 
16. Limitations and difficulties of the study: 
 
1. Constrained timeframe for research due to residency program obligations 
2. Ensuring an adequate sample size 
 
17. Rationale for subject selection and recruitment. 
This is a randomized control study, aiming to study the feasibility and 
contamination rate of urine collected by clean catch technique comparing to 
catheterization technique. The population enrolled in this study, pediatric patients, 
that will benefit of introducing clean catch technique. This is a population who 
cannot give urine sample for laboratory testing without catheterization which is a 
painful procedure. The clean catch technique will be of much help for this age 
group as it is painless and less invasive technique. Therefore, it seems highly 
beneficial to study the contamination rate of CCU collection in order to introduce it 
in local guidelines to replace the current use of catheterization. 
18. Statistical analysis: 
 
For data entry purposes Microsoft Excel software will be used and for the data 
analysis IBM SPSS statistics will be used. Normally distributed continuous data 
will be analyzed using student T test, if abnormal MANN-WHITNEY test will be 
used. For categorical comparisons CHI-square test will be applied. P-value of less 
than 0.05% will be considered as statistical significance. 

19. Criteria for terminating the study. 
A subject who is included in the study, and failed urine collection by CCU , will be 
removed from study and counted as CCU collection failure. After that to be 
managed by in-charged doctor as per the treating doctor plan.  
The full study to be terminated once required sample size reached, and all data is 
obtained and documented on the data collection sheet and transferred to Microsoft 
Excel software. 
20. Quality control and quality assurance. 
 
To ensure quality control of the data, we will take several steps.  
First, we will design and well-labeled data collection sheets to ensure that all 
relevant information is captured accurately and consistently. These sheets will be 
tailored to the specific needs of our study and will include clear instructions and 
guidelines for data collection. 
Second, we will train our research team on the standardized procedures for data 
collection, including how to complete the data collection sheets accurately and 
consistently. We will also conduct periodic spot checks and quality control checks 
to ensure that the data collected is accurate and complete. 
Third, we will use Microsoft Excel software to manage the data entry process. This 
software allows for easy data entry, validation, which will reduce the risk of errors 
during data management. 
Finally, we will conduct a thorough review of the data after it has been collected 
and entered into the system. This will include checking for inconsistencies, missing 
data, and outliers, and addressing any issues that are identified. By taking these 
steps, we will ensure that the data collected is of the highest quality and is suitable 
for analysis 
21. Data handling and record keeping. 
Subject information obtained because of this study is considered confidential and 
disclosure to third parties is prohibited. Medical information may be assessed only 
after approval from the subject to the investigator. The investigator will not 
disclose any confidential information regarding subjects during performance of 
study duties without justifiable reasons. The investigator affirms the subject’s right 
to protection against invasion of privacy. All data collection sheets are collected in 
a locked and secured box in the emergency department and no access is allowed 
except for investigators. Any electronic file containing patient data will be 
protected by a complicated password. No data will be shared though any social 
platforms including WhatsApp. Data can be shared between investigators only by 
password protected Google Drive account. After termination of the study and 

finishing data analysis, data will be stored for a period of 3 year and will be 
discarded safely and securely. 
 
22. Anticipated results 
 
We anticipate that our intervention will show a comparable methodology to the 
standard urinary catheterization in terms of contamination rate, but is less invasive 
and more feasible, with higher patient and parent satisfaction rates. This conclusion 
has the potential to improve patient care and management, as it offers a more 
patient-centered approach to catheterization. Our study may influence policy-
making by demonstrating the potential benefits of the intervention and advocating 
for its wider adoption in clinical practice. 
23. References: 
1- Shaikh, N., Morone, N. E., Bost, J. E., & Farrell, M. H. (2008). Prevalence of 
urinary tract infection in childhood: a meta-analysis. The Pediatric infectious 
disease journal, 27(4), 302-308. 
2- Nader, S. and Alejandro, H., 2021. Urinary tract infections in children: 
Epidemiology and risk factors. UpToDate, Waltham, MA, pp.1-19. (Accessed on 
January 01, 2023). 
3- Roberts, K.B. and Subcommittee on Urinary Tract Infection, Steering Committee 
on Quality Improvement and Management, 2011. Urinary tract infection: clinical 
practice guideline for the diagnosis and management of the initial UTI in febrile 
infants and children 2 to 24 months. Pediatrics, 128(3), pp.595-610. 
4- Schroeder, A. R., Newman, T. B., Wasserman, R. C., Finch, S. A., & Pantell, R. 
H. (2005). Choice of urine collection methods for the diagnosis of urinary tract 
infection in young, febrile infants. Archives of pediatrics & adolescent 
medicine, 159(10), 915-922. 
5- Tosif S, Baker A, Oakley E, et al. Contamination rates of different urine collection 
methods for the diagnosis of urinary tract infections in young children: an 
observational cohort study. J Paediatr Child Health 2012; 48:659. 
6- Labrosse M, Levy A, Autmizguine J, Gravel J. Evaluation of a New Strategy for 
Clean-Catch Urine in Infants. Pediatrics 2016; 138. 
7- Al-Orifi F, McGillivray D, Tange S, Kramer MS. Urine culture from bag 
specimens in young children: are the risks too high? J Pediatr 2000; 137:221. 
8- Bogie AL, Sparkman A, Anderson M, et al. Is There a Difference in the 
Contamination Rates of Urine Samples Obtained by Bladder Catheterization and 
Clean-Catch Collection in Preschool Children? Pediatr Emerg Care 2021; 37:e788. 
9- Ballouhey Q, Fourcade L, Couve-Deacon E, et al. Urine Contamination in 
Nontoilet-trained and Uncircumcised Boys. Urology 2016; 95:171. 

10- Badiee Z, Sadeghnia A, Zarean N. Suprapubic Bladder Aspiration or Urethral 
Catheterization: Which is More Painful in Uncircumcised Male Newborns? Int J 
Prev Med. 2014 Sep;5(9):1125-30. PMID: 25317295; PMCID: PMC4192774. 
11- Tej K. Mattoo, Nader Shaikh, Caleb P. Nelson; Contemporary Management of 
Urinary Tract Infection in Children. Pediatrics February 2021; 147 (2): 
e2020012138. 10.1542/peds.2020-012138 
12- Robert H. Pantell, Kenneth B. Roberts, William G. Adams, Benard P. 
Dreyer, Nathan Kuppermann, Sean T. O’Leary, Kymika Okechukwu, Charles R. 
Woods, SUBCOMMITTEE ON FEBRILE INFANTS; Clinical Practice 
Guideline: Evaluation and Management of Well-Appearing Febrile Infants 8 to 60 
Days Old. Pediatrics August 2021; 148 (2): e2021052228. 10.1542/peds.2021-
052228 
13- National Institute for Health and Care Excellence. (2007). Urinary tract infection 
in under 16s: diagnosis and management. Clinical guideline.. nice. org. 
uk/guidance/cg54. 
14- Altuntas, N., Celebi Tayfur, A., Kocak, M., Razi, H.C. and Akkurt, S., 2015. 
Midstream clean-catch urine collection in newborns: a randomized controlled 
study. European journal of pediatrics, 174(5), pp.577-582. 
15- Herreros, M.L., Tagarro, A., García-Pose, A., Sánchez, A., Cañete, A. and Gili, P., 
2015. Accuracy of a new clean-catch technique for diagnosis of urinary tract 
infection in infants younger than 90 days of age. Paediatrics & Child 
Health, 20(6), pp.e30-e32. 
16- Mulcrone, A.E., Parikh, M. and Ahmad, F.A., 2020. Reducing infant 
catheterization in the emergency department through clean‐catch urine 
collection. Journal of the American College of Emergency Physicians Open, 1(6), 
pp.1533-1541. 
 
 
 

24. Appendix 
 
Contents: 
 
- Data collection sheet 
- Written informed consent 
- Clean catch urine technique 
- Definitions for UTI, contamination, and insignificant growth 
- Study flow chart 
 
 
 

Data collection sheet 
Data Collection Sheet 
Patient demographics 
 
▪ Serial number: 
▪ MRN: 
▪ Name of the hospital: •  RH
 
,  ……  •  ANH
   
……  
▪ Age (in months):  
▪ Gender:        •  Male          •  female  
▪ Weight (Kg): 
 
Current illness: 
 
▪ Urinary Tract infection is one of the differential diagnosis 
▪ •  Yes                                 •  No 
▪ Urine collection by:   
▪ •  Clean Catch                    • Catheterization  
 
Duration of procedure 
(in minutes): …….. 
 
 
Pain Score (Neonatal 
infant pain Scale): 
…….. 
 
 
 
 
 
 
 
 
Specify time antibiotics giving (before/after clean catch or before/after catheterization?) 
…….. 
For the Doctor/nurse: Do you agree collecting urine using CCU(bladder massage) is easier 
than bladder catheterization? (Yes or No) …….. 
 
Parent satisfaction: are you satisfied with the used technique (Yes or No) …….. 
 
Physician name: …….. 
 
 
 
 
Signature: …….. 
 

Written informed consent: 
 
Informed consent form 
 
Research title 
 
Clean Catch Urine Feasibility and Contamination Rate compared to Bladder Catheterization 
Urine in Pre-Continent Children: Randomized Control Trial 
 
Research Idea 
Our study aims to test an alternative way to urine collection by catheterization. primary 
outcomes are to compare the contamination rates between the two method and parent 
satisfaction. The secondary outcomes, include procedure duration, pain score (using neonatal 
infant pain scale) 
 
Methodology 
The patient will be randomly distributed into two groups: group one, urine will be collected 
through catheterization, group two urine will be collected by Clean Catch urine collection. 
 
 
Contact information 
If you have any questions, you may ask now or later, even after the study has started. If you wish 
to ask questions later, you may contact any of the following: 
-Dr.Sulayyem Al Hasrousi , contact number +968 97383155, E-Mail: alharsoosi@gmail.com. 
- Dr. Dr. Muna Al Ka'abi, contact number +968 91797366, E-Mail: r2126@resident.omsb.org 
 
• I am the parent of …………………………………………………………….. 
• I have read the foregoing information, or it has been read to me. I have had the opportunity 
to ask questions about it.  
• Any questions that I asked, they have been answered to my satisfaction. I consent 
voluntarily to participate as a participant in this research. 
 
Authorized to consent name: 
Relationship to the patient: 
Signature date: 
Researcher/Doctor: 
 
 

Clean catch urine technique 
 
Clean catch urine (bladder massage technique) 
 
▪ Two people (trained nurses and/or physicians) were needed to perform the 
procedure, and a third to measure the time taken. This technique involves a 
combination of fluid intake and non-invasive bladder stimulation maneuvers.  
▪ To provide breast-feeding or formula intake appropriate to the age and weight 
of the newborn. In babies fed infant formula, 10 ml was provided on the first 
day of life, increasing to 10ml per day during the first week. From the second 
week onwards, 25 ml/kg were administered before the onset of stimulation.  
▪ Twenty-five minutes after feeding, the infant’s genitals were cleaned 
thoroughly with warm water and soap and dried with sterile gauze.  
▪ A sterile collector was placed near the baby to avoid losing urine samples. 
▪ Hold the baby under their armpits with their legs dangling. One examiner then 
starts bladder stimulation which consists of a gentle tapping in the suprapubic 
area at a frequency of 100 taps or blows per minute for 30 seconds.  
▪ Stimulation of the lumbar paravertebral zone in the lower back with a light 
circular massage for 30 s. Both stimulation maneuvers are repeated until 
micturition starts, and a midstream urine sample can be caught in a sterile 
collector. 
▪ Success is defined as the collection of a sample within 5 min of starting the 
stimulation maneuvers. 
 
 

Definitions for UTI, contamination, and insignificant growth 
 
 
Urine culture results 
Definition 
Urinalysis result 
Organism(s) Cultured 
Colony Threshold a 
No growth 
Negative 
No growth 
No growth 
UTI 
Positive b 
1 Uropathogen c 
≥100,000 CFU/mL 
 
Positive 
1 Uropathogen 
10,000–100,000 
CFU/mL d 
Contaminated 
Negative 
1 Non‐uropathogen 
≥100,000 CFU/mL 
 
Negative 
≥2 Organisms (≥1 non‐
uropathogen) 
Any colony count 
 
Negative 
Mixed bacterial flora e 
≥100,000 CFU/mL 
Insignificant 
Growth 
Positive or 
negative 
1 Non‐uropathogen 
≤10,000 CFU/mL 
 
Negative 
1 Non‐uropathogen 
≤100,000 CFU/mL 
 
aUrine culture colony counts had the same thresholds regardless of the method used to obtain the urine 
specimen (ie, urethral catheterization or bladder massage). 
bUrinalysis indicative for UTI‐labeled positive: positive leukocyte esterase test and/or nitrite test, in 
addition to evidence of pyuria with >10 white blood cells per microliter. Urinalysis results that do not 
meet criteria for positive are considered negative. 
cThe identified organism is considered a uropathogen based on clinical judgment of the provider caring 
for the patient. 
dFor this range, providers must consider the patient's clinical presentation and whether the urinalysis 
supports the diagnosis of a UTI. 
eNomenclature indicating growth of 3 or more organisms. 
 
 

Study flow chart