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

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ClinicalTrials.gov Identifier: NCT01159509
Recruitment Status : Unknown
Verified July 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2010
Last Update Posted : July 9, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Healthy Hypertrophic Pyloric Stenosis Behavioral: sodium taste tests

Study Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : September 2010
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011
Groups and Cohorts

Group/Cohort Intervention/treatment
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.


Outcome Measures

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

Eligibility Criteria

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 Posted: July 9, 2010    Key Record Dates
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