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

July 8, 2010 updated by: Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ayala Maayan-Metzger, Dr.
  • Phone Number: 972-54-6278248

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increased sodium intake
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

University of Haifa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 9, 2010

Last Update Submitted That Met QC Criteria

July 8, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-8021-AM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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