NCT06504771

Brief Summary

Study the demographic, clinical, laboratory and etiological profile of children with gross hematuria and trace the outcome of these patients for at least 3 months follow up.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

July 5, 2024

Last Update Submit

July 16, 2024

Conditions

Hematuria

Keywords

Gross hematuria

Outcome Measures

Primary Outcomes (1)

  • Investigate the creatinine level of the studied cases

    follow up of creatinine level in mg/dl of the studied cases

    three months

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

patients with gross hematuria at The pediatric department and pediatric nephrology outpatient clinic at Sohag University hospital, Sohag, Egypt

You may qualify if:

  • lnvestigators will include all patients complaining of gross hematuria between the ages of 1 month up to 16 years.

You may not qualify if:

  • Children with external perineal or genital region bleeding which may falsely cause presence of blood in urine samples.
  • Patients whose legal guardians will refuse participation in the study.
  • Patients with follow up for less than 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine,Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abdelrahim Sadek, Professor

    Faculty of Medicine, Sohag university, Egypt

    STUDY DIRECTOR

  • Ghada A Abd-Elrehim, Lecturer

    Faculty of Medicine, Sohag university, Egypt

    STUDY DIRECTOR

Central Study Contacts

Haya M AbdelHameed, Resident

CONTACT

01065860928haya011222@med.sohag.edu.eg

Rania G Mostafa, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric resident at sohag general hospital

Study Record Dates

First Submitted

July 5, 2024

First Posted

July 17, 2024

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

February 1, 2025

Last Updated

July 17, 2024

Record last verified: 2024-07

Locations

EG(1)