NCT04605835

Brief Summary

The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
655

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

6.9 years

First QC Date

October 8, 2020

Last Update Submit

October 21, 2020

Conditions

Keywords

obstructive uropathychildrenultrasoundDoppler

Outcome Measures

Primary Outcomes (1)

  • Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children.

    The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.

    up to 36 months

Study Arms (1)

Main group

484 children with congenital obstructive uropathies

Diagnostic Test: ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.

Interventions

The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.

Main group

Eligibility Criteria

Age3 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

60 in children with obstructive uropathies (30 children with congenital hydronephrosis and 30 children with congenital ureterohydronephrosis).

You may qualify if:

  • children with congenital obstruction of the upper urinary tract

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samarkand State Medical Institute

Samarkand, 140100, Uzbekistan

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2020

First Posted

October 28, 2020

Study Start

March 2, 2018

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations