Sonographic Follow up in Newborns Diagnosed With Prenatal... | NCT01780103

Studies
Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

NCT01780103

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jan 30, 2013Estimated

Enrollment

143Estimated

Phase

Not provided

Conditions

Pyelectasis of Newborns

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Jan 29, 2013

First Submission Date that Met QC Criteria

Jan 29, 2013

First Posted Date

Jan 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2013

Last Update Posted Date

Jan 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Sylvia Foldi, Neonatologist MD, Hillel Yaffe Medical CenterPrincipal Investigator

Lead Sponsor

Hillel Yaffe Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
severity of hydronephrosis by sonographic measures		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All newborns that were born at Hillel Yaffe Medical Center with prenatal diagnosis of Hydronephrosis between 01.01.2010-31.12.2012

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

newborns at the age of 0-1 months

Sampling Method

Non-Probability Sample