Urinary Tract Infections in ChildrenSONDAPUNCT03263845
Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness
An observational study of Urinary Tract Infections in Children, run by Rennes University Hospital at 1 site in France.
Trial summary
Observational study. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Urinary Tract Infections in Children
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2016to 13 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.
Who may be able to join
- Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Round-trip Survey or Urine Bag: Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)
Observational study.
Read the detailed description
Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2 years of age. Urinary samples are therefore very common in pediatric emergencies. In children who have not acquired cleanliness, the most used method of collection is the placement of a sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a bacteriological point of view this method is debatable because the rate of contamination of the collections is important. This mode of collection is of interest only to exclude a urinary infection, by the realization of a urinary strip.
Pocket-collected urine is not reliable for bacteriological analysis in culture. For example, if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling by urine sampling (or other invasive methods) for culture.
The urine bag should be changed every 30 minutes to avoid the risk of contamination. The technique is wait-and-see, the installation of several pockets is often necessary before obtaining urine.
A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary pouch was as much more painful than the urinary sounding, in the same patient. To our knowledge there is no other study dealing with the difference in pain engendered by these two methods.
Since the urinary catheterization is faster, bacteriologically justified and necessary if the pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a generalization of the urinary catheterization, as first intention, Having not acquired cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.
Many centers continue to use urinary pocket collection mainly, as the survey technique seems too invasive and painful.
- Conditions
- Urinary Tract Infections in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain
Score of the visual analog scale rated by the caregiver during the first performed gesture.
Measured: Day 0
Secondary outcomes (4)
Evaluation of pain
Score of the visual analog scale rated by the parent during the first performed gesture.
Measured: Day 0
Evaluation of pain
Score of the visual analog scale rated by the parent and the caregiver for the following gestures
Measured: Day 0
The experience of the gesture by the parent and the caregiver
Evaluation by a questionnaire by choosing from the following proposals:
Very well spent, well spent, badly spent or very badly spent
Measured: Day 0
Time needed to collect urine
Duration between the first gesture and the final urine collection
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start5 Jul 2016
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amelie Rickewaert, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263845
- Sponsor's protocol ID
- 35RC16_3036_SONDAPU
- Acronym
- SONDAPU
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Round-trip Survey or Urine Bag: Evaluation of Pain in Urinary Collections in Pediatric Emergencies in Children Who Have Not Acquired Cleanliness (SONDAPU)
- ClinicalTrials.gov ID
- NCT03263845
- Acronym / sponsor ID
- SONDAPU / 35RC16_3036_SONDAPU
- Conditions
- Urinary Tract Infections in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study.
Detailed description
Febrile urinary infections account for 5% of unexplained causes of fever in children up to 2 years of age. Urinary samples are therefore very common in pediatric emergencies. In children who have not acquired cleanliness, the most used method of collection is the placement of a sterile urine bag on the perineum. It allows a noninvasive urinary collection. However from a bacteriological point of view this method is debatable because the rate of contamination of the collections is important. This mode of collection is of interest only to exclude a urinary infection, by the realization of a urinary strip.
Pocket-collected urine is not reliable for bacteriological analysis in culture. For example, if the urine strip is positive, the American Academy of Pediatrics recommends urine sampling by urine sampling (or other invasive methods) for culture.
The urine bag should be changed every 30 minutes to avoid the risk of contamination. The technique is wait-and-see, the installation of several pockets is often necessary before obtaining urine.
A study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary pouch was as much more painful than the urinary sounding, in the same patient. To our knowledge there is no other study dealing with the difference in pain engendered by these two methods.
Since the urinary catheterization is faster, bacteriologically justified and necessary if the pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a generalization of the urinary catheterization, as first intention, Having not acquired cleanliness, requiring a withdrawal of urine for suspicion of urinary infection.
Many centers continue to use urinary pocket collection mainly, as the survey technique seems too invasive and painful.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.
Key inclusion criteria (1 listed)
- Children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in Rennes, where urine sampling is necessary in case of suspected urinary tract infection.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of pain
Time frame: Day 0
Score of the visual analog scale rated by the caregiver during the first performed gesture.
4 secondary outcomes
Evaluation of pain
Time frame: Day 0
Evaluation of pain
Time frame: Day 0
The experience of the gesture by the parent and the caregiver
Time frame: Day 0
Time needed to collect urine
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
Related trials for Urinary Tract Infections in Children
RecruitingObservational study
Urine Collection and Novel UTI Biomarkers in Children and Older Adults
UTI - Urinary Tract Infection
RecruitingPhase 4
Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children
Complicated Urinary Tract Infection, Infection
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Active, not recruitingPhase 2
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Meropenem-Vaborbactam in Children With Complicated Urinary Tract Infection, Including Acute Pyelonephritis
Acute Pyelonephritis, Complicated Urinary Tract Infection
RecruitingPhase 4
Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'
Urinary Tract Infection, Cellulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amelie Rickewaert principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infections in Children, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pain (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.