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Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Dr Sylvia Foldi, Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01780103
First Posted: January 30, 2013
Last Update Posted: January 30, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Sylvia Foldi, Hillel Yaffe Medical Center
  Purpose

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


Condition
Pyelectasis of Newborns

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

Further study details as provided by Dr Sylvia Foldi, Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • severity of hydronephrosis by sonographic measures [ Time Frame: 2 years ]

Estimated Enrollment: 143
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
newborns at the age of 0-1 months
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:

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Dr Sylvia Foldi, Neonatologist MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01780103     History of Changes
Other Study ID Numbers: HYMC-0055-12-CTIL
First Submitted: January 29, 2013
First Posted: January 30, 2013
Last Update Posted: January 30, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Hydronephrosis
Pyelectasis
Kidney Diseases
Urologic Diseases
Fetal Diseases
Pregnancy Complications
Urogenital Abnormalities
Congenital Abnormalities