NCT06905600

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 31, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 1, 2025

Status Verified

July 1, 2024

Enrollment Period

1.8 years

First QC Date

July 8, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

Pseudohypoaldosteronismpseudohypoaldosteronism in children

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Pseudohypoaldosteronism

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

July 8, 2024

First Posted

April 1, 2025

Study Start

January 31, 2024

Primary Completion

December 1, 2025

Study Completion

December 31, 2025

Last Updated

April 1, 2025

Record last verified: 2024-07

Locations