Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.

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.

Study Overview

• Status: Withdrawn
• Conditions: Hydronephrosis in Children
• Intervention / Treatment: Other: Ultrasonography with oral hydration; Radiation: Scintigraphy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67098
    • Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasonography sensibilized by oral hydratation; Ultrasonography before, 30 min and 90 min following hydratation.	Other: Ultrasonography with oral hydration; Before, 30 min and 90 min following oral hydration; Radiation: Scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	V2 (Age of 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Between V0 (age: 30 days ) and V2 (age: 6 months)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Isabelle LACREUSE, MD, Hopitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Estimate): October 2, 2015
• Last Update Submitted That Met QC Criteria: October 1, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: hydronephrosis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Hydronephrosis
• Other Study ID Numbers: 5580