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NCT05900375
Decision Aid for Parents of Infants With UPJO
NA trial testing Parent Decision Aid in Ureteropelvic Junction Obstruction in 100 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 100 |
| Start date | 21 January 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Parent Decision Aid
Conditions studied
- Ureteropelvic Junction Obstruction — all drugs for Ureteropelvic Junction Obstruction →
- Ureteropelvic Junction; Obstruction, Congenital — all drugs for Ureteropelvic Junction; Obstruction, Congenital →
Sponsor
University of Colorado, Denver
Who can join
Adults 18 to 89, any sex, with Ureteropelvic Junction Obstruction or Ureteropelvic Junction; Obstruction, Congenital. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05900375
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Related trials
Other recruiting trials for Ureteropelvic Junction Obstruction
Currently open trials in the same condition.
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- NCT06382233 — The PRO-FUTURE Project · recruiting
Other University of Colorado, Denver trials
Trials by the same sponsor.
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- NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05900375 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
- Last refreshed: 23 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05900375.
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