Urinary Tract AnomaliesCAKUTNCT06534749
Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates
An observational study of Urinary Tract Anomalies and Kidney; Anomaly, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 1 month
- Conditions the study is for
- Urinary Tract Anomalies, Kidney; Anomaly
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Oct 2023to Oct 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: neonates who will be born or admitted at Tanta University Hospital.
Who may be able to join
- Neonates in the first month of life.
Who cannot join
- no exclusions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- ultrasound
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start28 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract AnomaliesStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- Sara Mabrouk Mohamed Elghoul, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534749
- Sponsor's protocol ID
- 36264PR377/10/23
- Acronym
- CAKUT
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates
- ClinicalTrials.gov ID
- NCT06534749
- Acronym / sponsor ID
- CAKUT / 36264PR377/10/23
- Conditions
- Urinary Tract Anomalies, Kidney; Anomaly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 28 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 3 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- neonates who will be born or admitted at Tanta University Hospital.
Key inclusion criteria (1 listed)
- Neonates in the first month of life.
Key exclusion criteria (1 listed)
- no exclusions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundUltrasound 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 | Device | – |
Primary outcome
Incidence of CAKUT in neonates
Time frame: one year
investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mabrouk Mohamed Elghoul, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Anomalies and Kidney; Anomaly, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CAKUT in neonates (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.