Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation (TPHA)

Transient Pseudohypoaldosteronism Affecting Children With Urinary Tract Malformation: Diagnosis and Management in a French Retrospective Study

Pseudohypoaldosteronism is a pathology affecting children under 6 months of age, little known but which can have serious consequences.

There are no real figures on the prevalence of this pathology in France. The exact pathophysiology is not known and the management is not currently codified.

This is why it is interesting to study this pathology and its treatment on a national scale in order to think about the best possible treatment, as well as to raise awareness of this pathology among different health professionals.

Study Overview

• Status: Recruiting
• Conditions: Pseudohypoaldosteronism

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Ariane ZALOSZYC, MD; Phone Number: 33 3 88 12 77 42; Email: ariane.zaloszyc@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service pédiatrie 1 - CHU de Strasbourg - France
    • Contact: Ariane ZALOSZYC, MD; Phone Number: 33 3 88 12 77 42; Email: ariane.zaloszyc@chru-strasbourg.fr
    • Principal Investigator: Ariane Zaloszyc, MD
    • Sub-Investigator: Inès BERNHARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Minor subjects aged less than 6 years at the time of diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023

Description

Inclusion Criteria:

• Minor subjects aged less than 6 years at the time of diagnosis
• Diagnosis of pseudohypoaldosteronism in the context of urinary malformation and/or urinary infection between January 1, 2018 and December 31, 2023
• Subject (and/or their parental authority) having not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

• Subject (or their parents) having expressed their (their) opposition to participating in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National comparison of clinical and therapeutic practices concerning the management of pseudohypoaldosteronism in children with urinary malformations and/or urinary infections	This study compares clinical and therapeutic practices The retrospective analysis of the data will be carried out using classic statistical tests (Student's test, Fisher's test, ROC curve)	Up to 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: March 25, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Pseudohypoaldosteronism; pseudohypoaldosteronism in children
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Renal Tubular Transport, Inborn Errors; Pseudohypoaldosteronism
• Other Study ID Numbers: 9139

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No