Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates

NCT ID: NCT06534749

Last Updated: 2024-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-28
• Study Completion Date: 2024-10-31

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.

Detailed Description

This cross sectional study will be conducted for one year from October 2023 to October 2024 at Pediatric and Radiology Departments Tanta University Hospital (TUH).

This study will be conducted on neonates who will be born or admitted at Tanta University Hospital.

All patients included in the study will be subjected to: history taking, clinical examination and 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.

Conditions

Urinary Tract Anomalies; Kidney; Anomaly

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Neonates in the first month of life.

Exclusion Criteria

• no exclusions

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mabrouk Elghoul

lectrurer of pediatric nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Mabrouk Mohamed Elghoul, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

Sara Mabrouk Mohamed Elghoul

Tanta, Tanta, Qism 1, Egypt

Countries

Egypt

Other Identifiers

36264PR377/10/23

Identifier Type: -

Identifier Source: org_study_id