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NCT05900375 · ClinicalTrials.gov registry record · NA

Decision Aid for Parents of Infants With UPJO

A NA study of Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital, sponsored by University of Colorado, Denver.

Recruiting
Registry status
NA
Development phase
100
Enrollment target
1
Study location

NCT05900375 is a NA study of Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT05900375, a NA study of Ureteropelvic Junction Obstruction and Ureteropelvic Junction; Obstruction, Congenital, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
NA
Development phase
100 participants
Enrollment target
1
Study location

Study Summary

Ureteropelvic junction obstruction (UPJO) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the U.S. The goal of surgical treatment of UPJO is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60% of infants with high-grade hydronephrosis.1-However, the benefit of early surgery compared to observation and potential later surgery to preserve kidney function has not been well-defined. Consequently, surgeons differ on whether to initially treat with surgery or observation, with surgical rates in the first year of life varying from 15-50% across surgical practices. These variations are important to understand, as the decision for early surgery is not without risk. Prior studies suggest that infants treated surgically are at higher risk for readmission and reoperation. Early surgery also raises concerns about neurodevelopmental effects of anesthetic exposure. To address this gap, the purpose of this pilot test is to develop a patient decision aid (PtDA) tool and pilot test its effect on parental understanding and engagement in the decision-making process at Children's Hospital Colorado. The proposed pilot is a necessary first step in preparation for a future multicenter hybrid effectiveness-implementation trial. This work will also be used to support future studies evaluating the impact of a PtDA on surgical variations and treatment outcomes in patients with UPJO and other complex congenital urologic anomalies.

Interventions

  • BEHAVIORAL Parent Decision Aid

Study Locations (1)

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-01-21
Est. Completion 2025-12-31
Phase NA

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT05900375

The ClinicalTrials.gov registry entry for NCT05900375 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ureteropelvic Junction Obstruction appearing as the primary indexed condition, and to 1 intervention - of which Parent Decision Aid is the first listed.

NCT05900375 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT05900375 about?

NCT05900375 is a clinical study titled "Decision Aid for Parents of Infants With UPJO". Ureteropelvic junction obstruction (UPJO) is the most common etiology of high-grade hydronephrosis, affecting approximately 4,000-10,000 infants annually in the U.S. The goal of surgical treatment of UPJO is to minimize the risk of kidney damage associated with obstruction, which may occur in 30-60%...

What is the current status of trial NCT05900375?

This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-01-21. Estimated completion is 2025-12-31.

What conditions does trial NCT05900375 study?

This clinical trial studies the following conditions: Ureteropelvic Junction Obstruction, Ureteropelvic Junction; Obstruction, Congenital.

What interventions are being tested in trial NCT05900375?

The interventions under investigation include: Parent Decision Aid (BEHAVIORAL).

Who is sponsoring clinical trial NCT05900375?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05900375 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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