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Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.

Primary Purpose

Hydronephrosis in Children

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ultrasonography with oral hydration
Scintigraphy
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hydronephrosis in Children focused on measuring hydronephrosis

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • child of 30 days old or less
  • unilateral or bilateral hydronephrosis (pelvis > 5mm )

Exclusion Criteria:

  • complex uropathy
  • diuretic administration 6 hours prior to ultrasonography or scintigraphy
  • oral feeding trouble

Sites / Locations

  • Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasonography sensibilized by oral hydratation

Arm Description

Ultrasonography before, 30 min and 90 min following hydratation.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

Full Information

First Posted
February 18, 2014
Last Updated
October 1, 2015
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02086760
Brief Title
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
Official Title
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Withdrawn
Why Stopped
no subject enrolled within one year following EC and IRB approvals.
Study Start Date
May 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydronephrosis in Children
Keywords
hydronephrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonography sensibilized by oral hydratation
Arm Type
Experimental
Arm Description
Ultrasonography before, 30 min and 90 min following hydratation.
Intervention Type
Other
Intervention Name(s)
Ultrasonography with oral hydration
Intervention Description
Before, 30 min and 90 min following oral hydration
Intervention Type
Radiation
Intervention Name(s)
Scintigraphy
Primary Outcome Measure Information:
Title
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
Description
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)
Time Frame
V2 (Age of 6 months)
Secondary Outcome Measure Information:
Title
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
Description
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)
Time Frame
Between V0 (age: 30 days ) and V2 (age: 6 months)

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: child of 30 days old or less unilateral or bilateral hydronephrosis (pelvis > 5mm ) Exclusion Criteria: complex uropathy diuretic administration 6 hours prior to ultrasonography or scintigraphy oral feeding trouble
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle LACREUSE, MD
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France

12. IPD Sharing Statement

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Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.

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