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Sonographic Follow up in Newborns Diagnosed With Prenatal Hydronephrosis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr Sylvia Foldi, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01780103
First received: January 29, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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 Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • severity of hydronephrosis by sonographic measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: January 29, 2013
Last Updated: January 29, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014