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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Haifa
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01159509
First received: July 8, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Increased sodium intake [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
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
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159509

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

Sponsors and Collaborators
Sheba Medical Center
University of Haifa
  More Information

No publications provided

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01159509     History of Changes
Other Study ID Numbers: SHEBA-10-8021-AM-CTIL
Study First Received: July 8, 2010
Last Updated: July 8, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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
Gastric Outlet Obstruction
Hypertrophy
Pyloric Stenosis
Pyloric Stenosis, Hypertrophic
Digestive System Diseases
Gastrointestinal Diseases
Pathological Conditions, Anatomical
Stomach Diseases

ClinicalTrials.gov processed this record on November 20, 2014