Pyelectasis of NewbornsNCT01780103
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
An observational study of Pyelectasis of Newborns, run by Hillel Yaffe Medical Center.
Trial summary
In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Pyelectasis of Newborns
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Jan 2014
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: newborns at the age of 0-1 months
Who may be able to join
- All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012
Who cannot join
- None
About this study
In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test.
These babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month.
The investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies
- Conditions
- Pyelectasis of Newborns
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of hydronephrosis by sonographic measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyelectasis of NewbornsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Sylvia Foldi, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780103
- Sponsor's protocol ID
- HYMC-0055-12-CTIL
- Status last verified
- Jan 2013
- First submitted
- 29 Jan 2013
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
- ClinicalTrials.gov ID
- NCT01780103
- Acronym / sponsor ID
- HYMC-0055-12-CTIL
- Conditions
- Pyelectasis of Newborns
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 30 Jan 2013 (estimated)
- 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.
In this retrospective study the investigators will enroll newborns that were born between 01.01.2010 and 31.12.2012 in Hillel Yaffe Medical Center with the prenatal diagnosis of Pyelectasis according to prenatal sonographic screening test.
These babies underwent renal sonography at the age of 2-5 days according to the protocol and were invited to an additional renal sonographic screening test at the age of 1 month.
The investigators will compare the results of the 2 examinations and the investigators will try to reach conclusions whether there is correspondence between the severity of the pyelectasis in the first and second sonographic tests and the outcome of these newborn babies
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborns at the age of 0-1 months
Key inclusion criteria (1 listed)
- All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
severity of hydronephrosis by sonographic measures
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyelectasis of Newborns, run by Hillel Yaffe Medical Center.
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 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
severity of hydronephrosis by sonographic measures (time frame: 2 years). 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 30 Jan 2013.