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The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodium Intake in Childhood

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 July 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159509
First Posted: July 9, 2010
Last Update Posted: July 9, 2010
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.
Collaborator:
University of Haifa
Information provided by:
Sheba Medical Center
  Purpose
The loss of sodium during infancy causes long term changes in sodium intake. Human research shows that the loss of maternal sodium during pregnancy and neonatal after birth causes an increase sodium intake during childhood. A study that examined sodium intake among infants that were treated with diuretics during the post-natal period found changes in sodium intake compared to controls. In this study we will test sodium intake in young children who have suffered from vomiting due to Hypertrophic Pyloric stenosis during early infancy.

Condition Intervention
Healthy Hypertrophic Pyloric Stenosis Behavioral: sodium taste tests

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Increased sodium intake [ Time Frame: 1 year ]

Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Infants ages -13 years that had HPS in infancy Behavioral: sodium taste tests
The cohort group will had sodium taste tests and an interview regarding diat habits.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children ages 7-13 years. Status post HPS in infancy
Criteria

Inclusion Criteria:

  • Children ages 7-13 years
  • Status post HPS in infancy

Exclusion Criteria:

  • Children with chronic diseases
  • Hospitalization due to dehydration after HPS hospitalization
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01159509


Contacts
Contact: Ayala Maayan-Metzger, Dr. 972-54-6278248

Sponsors and Collaborators
Sheba Medical Center
University of Haifa
  More Information

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01159509     History of Changes
Other Study ID Numbers: SHEBA-10-8021-AM-CTIL
First Submitted: July 8, 2010
First Posted: July 9, 2010
Last Update Posted: July 9, 2010
Last Verified: July 2010

Keywords provided by Sheba Medical Center:
hypertrophic pyloric stenosis
sodium intake
Healthy children with no chronic diseases
Status post HPS

Additional relevant MeSH terms:
Constriction, Pathologic
Hypertrophy
Pyloric Stenosis
Gastric Outlet Obstruction
Pyloric Stenosis, Hypertrophic
Pathological Conditions, Anatomical
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases