Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

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. Identifier: NCT01780103
Recruitment Status : Unknown
Verified January 2013 by Dr Sylvia Foldi, Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Dr Sylvia Foldi, Hillel Yaffe Medical Center

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

Condition or disease
Pyelectasis of Newborns

Study Type : Observational
Estimated Enrollment : 143 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

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

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

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:

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

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