Hydronephrosis in ChildrenNCT02086760
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
A study testing Ultrasonography with oral hydration and Scintigraphy in people with Hydronephrosis in Children, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Hydronephrosis in Children
- What is being tested?
- Ultrasonography with oral hydration and Scintigraphy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Nov 2016
- 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child of 30 days old or less
- unilateral or bilateral hydronephrosis (pelvis > 5mm )
Who cannot join
- complex uropathy
- diuretic administration 6 hours prior to ultrasonography or scintigraphy
- oral feeding trouble
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg
Strasbourg, 67098
About this study
Official title: Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.
- Conditions
- Hydronephrosis in Children
- Being tested
- Ultrasonography with oral hydration, Scintigraphy
- Keywords
- hydronephrosis
- Medical subject headings
- Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography with oral hydrationOther
Before, 30 min and 90 min following oral hydration
ScintigraphyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography sensibilized by oral hydratation | Experimental | Ultrasonography before, 30 min and 90 min following hydratation. Receives: Other: Ultrasonography with oral hydration; Radiation: Scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
The primary outcome measure is a composite outcome measure consisting of multiple measures.
Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydratation and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size.
The measures will be done before, 30 min and 90 min following oral hydration.
For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed.
The result will be reported as a single value, ie:
- the treating surgeon's decision and the independent surgeon's decision are similar (=1) or
- the treating surgeon's decision and the independent surgeon's decision are not similar (=0)
Measured: V2 (Age of 6 months)
Secondary outcomes (1)
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
The secondary outcome measure is a composite outcome measure consisting of multiple measures.
Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydration and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography with oral hydration, he will make a decision aposteriori.
For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size.
The measures will be done before, 30 min and 90 min following oral hydration.
For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed.
The result will be reported as a single value, ie:
- the treating surgeon's decision and the independent surgeon's decision are similar (=1) or
- the treating surgeon's decision and the independent surgeon's decision are not similar (=0)
Measured: Between V0 (age: 30 days ) and V2 (age: 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Why it stopped: no subject enrolled within one year following EC and IRB approvals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydronephrosis in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle LACREUSE, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086760
- Sponsor's protocol ID
- 5580
- Status last verified
- Oct 2015
- First submitted
- 18 Feb 2014
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
- ClinicalTrials.gov ID
- NCT02086760
- Acronym / sponsor ID
- 5580
- Conditions
- Hydronephrosis in Children
- Keywords
- hydronephrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no subject enrolled within one year following EC and IRB approvals.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 13 Mar 2014 (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.
Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography sensibilized by oral hydratation | Experimental | Other: Ultrasonography with oral hydration, Radiation: ScintigraphyUltrasonography before, 30 min and 90 min following hydratation. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child of 30 days old or less
- unilateral or bilateral hydronephrosis (pelvis > 5mm )
Key exclusion criteria (3 listed)
- complex uropathy
- diuretic administration 6 hours prior to ultrasonography or scintigraphy
- oral feeding trouble
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 |
|---|---|---|
| Ultrasonography with oral hydrationBefore, 30 min and 90 min following oral hydration | Other | Ultrasonography sensibilized by oral hydratation |
| Scintigraphy | Radiation | Ultrasonography sensibilized by oral hydratation |
Primary outcome
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
Time frame: V2 (Age of 6 months)
The primary outcome measure is a composite outcome measure consisting of multiple measures. Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydratation and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size. The measures will be done before, 30 min and 90 min following oral hydration. For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed. The result will be reported as a single value, ie: * the treating surgeon's decision and the independent surgeon's decision are similar (=1) or * the treating surgeon's decision and the independent surgeon's decision are not similar (=0)
1 secondary outcome
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
Time frame: Between V0 (age: 30 days ) and V2 (age: 6 months)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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.
Isabelle LACREUSE, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography with oral hydration and Scintigraphy in people with Hydronephrosis in Children, run by University Hospital, Strasbourg, France 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 2 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: withdrawn, as of the sponsor's last update on 2 Oct 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care (time frame: V2 (Age of 6 months)). 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 2 Oct 2015.