Urinary InfectionLINIPOCHENCT01659190
The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
A study testing Oiled-limestone liniment in people with Urinary Infection, run by University Hospital, Limoges at 1 site in France.
Trial summary
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Urinary Infection
- What is being tested?
- Oiled-limestone liniment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to Dec 2013
- Phase
- Interventional
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The children of zero in 36 months
- Children whose legal representatives accept the participation in the study
- the children must be affiliated or benefit from a health insurance scheme
Who cannot join
- Child of more than three years old
- Premature Child
- History of collection bag
- Irritated Siege
- Diarrhea
Trial locations and contacts
1 site in 1 country.
About this study
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags.
Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Read the detailed description
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags. This nursing care, extensively recommended for young children, was the subject of a study (still in progress) in 2009 conducted by the nurses of the CHU of Limoges and the CHI of Poissy. The results have shown that the removal of the collecting bags could involve pains as severe, or even worse, as the ones observed during a urinary catheter.
The lack of documentation and stunning results of our 2009 study persuaded healthcare teams to carry on their researches and posed the following problem: the removal of the collecting bags can cause an acute pain which could result in a major discomfort for a child under 3.
In practice, the removal of the collecting bag is made without any special precautions, or with the use of several products such as the Oiled-limestone liniment. This non-medicated product, commonly used for the care of the infant seat, intra and extra hospital field, would facilitate the removal of adhesives and plasters, according to the empirical experience of caregivers. Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Thanks to studies in usual care among different medical centers, that would be randomized and blindly conducted, healthcare teams would like to verify the hypothesis that the use of Oiled-limestone liniment could reduce acute pain involved in the removal of urine collecting bags among children under 36 months old. The study will be submitted to the parents of children aged 0 to 36 months old admitted to the pediatric emergency and needing a urine sample using a collecting bag.
The method of pain evaluation with the FLACC scale will be carried out as following: a caregiver will remove the collecting bag, with or without the use of the Oiled-limestone liniment, according to a prior randomized draw, and, at the same time, a second caregiver will film the care in order to provide experts assigned to measure objectively the level of the pain felt by the child during the care with videos.
Based on 136 children, during 24 months, this study would imply 3 inclusions in every medical center each month. Each inclusion should last 30 minutes.
Expected benefits would be, at first, improvement in the quality of healthcare for young children and improvement in the practice of the nurses, the nursery nurses, the auxiliaries of child welfare and the caregivers. This study would also suggests new recommendations for a good practice of nursing care, with accurate guidelines helping with the removal of collecting bags among children under 3.
- Conditions
- Urinary Infection
- Being tested
- Oiled-limestone liniment
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oiled-limestone linimentOther
| Study group | Role | What they receive |
|---|---|---|
| Oiled-limestone liniment | Experimental | the removal of the collecting bag is made with the Oiled-limestone liniment. Receives: Other: Oiled-limestone liniment |
| without Oiled-limestone liniment | No intervention | the removal of the collecting bag is made without any special precautions |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of pain measured by the FLACC scale
Measured: 5 minutes
Secondary outcomes (1)
Comparison at the girls and the boys of the score of the FLACC scale
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles LAMY, Study director, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659190
- Sponsor's protocol ID
- I10028
- Acronym
- LINIPOCHE
- Status last verified
- Jun 2012
- First submitted
- 3 Aug 2012
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Lamy C, Loizeau V, Couquet C, Sturtzer C, Fluteau C, Dugas M, Labrunie A, Marin B, Desfougeres JL, Bahans C, Guigonis V, Beloni P. Pain experienced by infants and toddlers at urine collection bag removal: A randomized, controlled, clinical trial. Int J Nurs Stud. 2019 Jul;95:1-6. doi: 10.1016/j.ijnurstu.2019.03.014. Epub 2019 Mar 23.
PubMed 30981953
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Painful Real-life Experience of the Child of Less Than Three Years During the Removal of the Collecting Bags in the Pediatric Urgency: What Strategy of Coverage?
- ClinicalTrials.gov ID
- NCT01659190
- Acronym / sponsor ID
- LINIPOCHE / I10028
- Conditions
- Urinary Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Aug 2012 (estimated)
- 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.
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags.
Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Detailed description
Urinary infection is one of the most common bacterial infections in pediatrics and requires urine collections to be diagnosed. In France, among children under 3, urine samples are collected thanks to collecting bags. This nursing care, extensively recommended for young children, was the subject of a study (still in progress) in 2009 conducted by the nurses of the CHU of Limoges and the CHI of Poissy. The results have shown that the removal of the collecting bags could involve pains as severe, or even worse, as the ones observed during a urinary catheter.
The lack of documentation and stunning results of our 2009 study persuaded healthcare teams to carry on their researches and posed the following problem: the removal of the collecting bags can cause an acute pain which could result in a major discomfort for a child under 3.
In practice, the removal of the collecting bag is made without any special precautions, or with the use of several products such as the Oiled-limestone liniment. This non-medicated product, commonly used for the care of the infant seat, intra and extra hospital field, would facilitate the removal of adhesives and plasters, according to the empirical experience of caregivers. Work teams have set as their main goal to compare the different levels of acute pain involved for children under 3 during the removing of the collecting bag, depending on the use, or not, of the Oiled-limestone liniment (randomized into 2 parallel groups), with, as a main endpoint, the difference between the results assigned to the acute pain by a pain evaluation scale (FLACC: Face-Legs-Activity-Cry-Consolability).
Thanks to studies in usual care among different medical centers, that would be randomized and blindly conducted, healthcare teams would like to verify the hypothesis that the use of Oiled-limestone liniment could reduce acute pain involved in the removal of urine collecting bags among children under 36 months old. The study will be submitted to the parents of children aged 0 to 36 months old admitted to the pediatric emergency and needing a urine sample using a collecting bag.
The method of pain evaluation with the FLACC scale will be carried out as following: a caregiver will remove the collecting bag, with or without the use of the Oiled-limestone liniment, according to a prior randomized draw, and, at the same time, a second caregiver will film the care in order to provide experts assigned to measure objectively the level of the pain felt by the child during the care with videos.
Based on 136 children, during 24 months, this study would imply 3 inclusions in every medical center each month. Each inclusion should last 30 minutes.
Expected benefits would be, at first, improvement in the quality of healthcare for young children and improvement in the practice of the nurses, the nursery nurses, the auxiliaries of child welfare and the caregivers. This study would also suggests new recommendations for a good practice of nursing care, with accurate guidelines helping with the removal of collecting bags among children under 3.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oiled-limestone liniment | Experimental | Other: Oiled-limestone linimentthe removal of the collecting bag is made with the Oiled-limestone liniment. |
| without Oiled-limestone liniment | No intervention | –the removal of the collecting bag is made without any special precautions |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The children of zero in 36 months
- Children whose legal representatives accept the participation in the study
- the children must be affiliated or benefit from a health insurance scheme
Key exclusion criteria (5 listed)
- Child of more than three years old
- Premature Child
- History of collection bag
- Irritated Siege
- Diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oiled-limestone liniment | Other | Oiled-limestone liniment |
Primary outcome
The level of pain measured by the FLACC scale
Time frame: 5 minutes
1 secondary outcome
Comparison at the girls and the boys of the score of the FLACC scale
Time frame: 5 minutes
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 30 Jul 2025.
- Results publication: PubMed 30981953Lamy C, Loizeau V, Couquet C, Sturtzer C, Fluteau C, Dugas M, Labrunie A, Marin B, Desfougeres JL, Bahans C, Guigonis V, Beloni P. Pain experienced by infants and toddlers at urine collection bag removal: A randomized, controlled, clinical trial. Int J Nurs Stud. 2019 Jul;95:1-6. doi: 10.1016/j.ijnurstu.2019.03.014. Epub 2019 Mar 23.
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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.
Charles LAMY study director
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oiled-limestone liniment in people with Urinary Infection, run by University Hospital, Limoges 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 3 inclusion and 5 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 30 Jul 2025. 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?
The level of pain measured by the FLACC scale (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01659190, which also lists 1 linked publication.
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 30 Jul 2025.