Hirschsprung DiseaseNCT04837963
Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children
An observational study of Hirschsprung Disease and Febrile Urinary Tract Infection (Disorder), run by University Hospital, Montpellier at 1 site in France.
Trial summary
Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure [7]. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Hirschsprung Disease, Febrile Urinary Tract Infection (Disorder)
- How many people
- 630 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2021to 30 Jul 2021
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cases were patients who underwent surgical treatment of an HD confirmed on histopathologic exam. Controls were children who underwent an appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease.. Two controls were matched for age and sex, at least included for each case
Who may be able to join
- Patients :
- surgical treatment of an HD confirmed on histopathologic exam.
- Controls :
- appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease
Who cannot join
- patients with HD but not yet operated
- patient with a stoma at the time of the study
- patient with chronic intestinal pseudo obstruction without HD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children ? A Case-control Study
Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure [7]. They are more often isolated but some FUTIs may reveal an underlying and facilitating condition. Beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for FUTI are reported. Age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (BBD) including dysfunctional voiding pattern and constipation increase the risk of FUTI. The prevalence of BBD in children with FUTIs is far higher than in the general population. Recommendations emphasize on an efficient treatment of BBD in the first-line management of recurring FUTIs and it has been proven to be efficient (ref).
One of the BBD may include Hirschsprung's Disease (HD). HD is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. It's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). The treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. But significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. Bladder dysfunction and associated urological anomalies are also reported in these patients. All of that may facilitate the occurrence of febrile urinary tract infections (FUTI) in patients with HD. Unfortunately, few studies focused on this specific population.
The objective of this study was to find out whether children with HD are more prone to develop FUTIs than controls and which patient with HD are more at risk to develop UTIs.
- Keywords
- Pediatric Surgery, Case Control study
- Medical subject headings
- Hirschsprung Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the risk of febril urinary tract infection
Compare the risk of febril urinary tract infection between children with Hirschsprung disease and control Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C and C-reactive protein (CRP) above 50 mg/
Measured: Day 1
Secondary outcomes (2)
Compare the age at the time of febrile urinary tract infection
Compare the age at the time of febrile urinary tract infection between children with Hirschsprung disease and control. This event could occur sooner in children with Hirschsprung disease than controls.
Measured: Day 1
Febrile urinary tract infection risk factor
Febrile urinary tract infection risk factor for children with Hirschsprung disease based upon the form of the disease, kinf of surgery, functional results For each patient treated by Hirschsprung disease, surgical technique, the level of involvement and the functional outcome will be collected.
The functional outcome was evaluated through the number of stool per day, the presence of soiling, the need of additional antegrade or retrograde colonic enema
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start16 May 2021
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas KALFA, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837963
- Sponsor's protocol ID
- RECHMPL21_0225
- Status last verified
- Oct 2021
- First submitted
- 6 Apr 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hirschsprung Disease Increase the Risk of Febrile Urinary Tract Infection in Children ? A Case-control Study
- ClinicalTrials.gov ID
- NCT04837963
- Acronym / sponsor ID
- RECHMPL21_0225
- Keywords
- Pediatric Surgery, Case Control study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 8 Apr 2021 (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.
Febrile urinary tract infection (FUTIs) are the most common bacterial infections in children under the age of 2 years. They represent 7% of children presenting with fever without a source. In case of recurrent or undertreated FUTIs there is a risk for kidney function with the threat of chronic renal failure [7]. They are more often isolated but some FUTIs may reveal an underlying and facilitating condition. Beside the well-known congenital anomalies of the kidneys and urinary tract such as reflux or obstructions, others risk factors for FUTI are reported. Age less than 1 year, uncircumcised males, poor fluid intake, bladder bowel dysfunction (BBD) including dysfunctional voiding pattern and constipation increase the risk of FUTI. The prevalence of BBD in children with FUTIs is far higher than in the general population. Recommendations emphasize on an efficient treatment of BBD in the first-line management of recurring FUTIs and it has been proven to be efficient (ref).
One of the BBD may include Hirschsprung's Disease (HD). HD is the first congenital malformation of the enteric nervous system with a reported prevalence of 1 in 5000 live birth. It's characterized by an aganglionosis and subsequent dysmotility affect by always the anal canal, most commonly there is a rectosigmoid form (74-80%), and less commonly involves a long segment of colon (12-22%) or a total colonic aganglionosis with ileal involvement upto 50 cm proximal to ileocecal junction (4-13%). The treatment is based on the resection of dysfunctional segment of colon with an anastomosis between the normally innervated bowel to the anus, while preserving normal sphincter function. But significant bowel dysfunction may persist postoperatively. 20% of the children present a fecal incontinence, and 14% a constipation in long-term studies. Bladder dysfunction and associated urological anomalies are also reported in these patients. All of that may facilitate the occurrence of febrile urinary tract infections (FUTI) in patients with HD. Unfortunately, few studies focused on this specific population.
The objective of this study was to find out whether children with HD are more prone to develop FUTIs than controls and which patient with HD are more at risk to develop UTIs.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cases were patients who underwent surgical treatment of an HD confirmed on histopathologic exam. Controls were children who underwent an appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease.. Two controls were matched for age and sex, at least included for each case
Key inclusion criteria (4 listed)
- surgical treatment of an HD confirmed on histopathologic exam.
- appendicetomy for acute appendicitis without history of HD, ano rectal malformation or any other colic disease
Key exclusion criteria (3 listed)
- patients with HD but not yet operated
- patient with a stoma at the time of the study
- patient with chronic intestinal pseudo obstruction without HD
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
Compare the risk of febril urinary tract infection
Time frame: Day 1
Compare the risk of febril urinary tract infection between children with Hirschsprung disease and control Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C and C-reactive protein (CRP) above 50 mg/
2 secondary outcomes
Compare the age at the time of febrile urinary tract infection
Time frame: Day 1
Febrile urinary tract infection risk factor
Time frame: Day 1
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 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Nicolas KALFA study director
University Hospital, Montpellier
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 Hirschsprung Disease and Febrile Urinary Tract Infection (Disorder), run by University Hospital, Montpellier 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 4 inclusion and 3 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 19 Oct 2021. 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?
Compare the risk of febril urinary tract infection (time frame: Day 1). 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 19 Oct 2021.