NCT06534749

Brief Summary

This cross sectional study will be conducted to investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

October 28, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

July 30, 2024

Last Update Submit

August 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of CAKUT in neonates

    investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.

    one year

Interventions

Ultrasound screening: by (SonoScape A6, Yizhe Building, Yuquan, Road Shenzhen, 518051, China). General-purpose diagnostic abdominal ultrasound equipment was used, with a 7.5-MHz linear-type probe. Screenings will be performed by radiologist with appropriate practice. The ultrasound examination will take 10 min for each patient. The recordings will consist of two bilateral renal images will be obtained and one transverse and longitudinal images. The urinary bladder will be observed with the patient in a supine position, and images will be recorded when abnormalities will be identified. The following will be investigated by ultrasound: number, size (including differences between sides), and location of the kidneys; pelvic dilatation; echogenicity, and other findings indicating cysts or tumours. Shape and wall thickening of the urinary bladder, as well as ureter dilatation, will be also examined

Eligibility Criteria

Age3 Days - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

neonates who will be born or admitted at Tanta University Hospital.

You may qualify if:

  • Neonates in the first month of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara Mabrouk Mohamed Elghoul

Tanta, Tanta, Qism 1, 31511, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Sara Mabrouk Mohamed Elghoul, MD

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lectrurer of pediatric nephrology

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

October 28, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Locations