The Effect of Hypertrophic Pyloric Stenosis (HPS) on Sodi... | NCT01159509

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

NCT01159509

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Jul 9, 2010Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Healthy
Hypertrophic Pyloric Stenosis

Interventions

sodium taste tests

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jul 2011Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Jul 8, 2010

First Submission Date that Met QC Criteria

Jul 8, 2010

First Posted Date

Jul 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2010

Last Update Posted Date

Jul 9, 2010Estimated

Name	Class
University of Haifa	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants ages -13 years that had HPS in infancy			Behavioral: sodium taste tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium taste tests	Behavioral	The cohort group will had sodium taste tests and an interview regarding diat habits.	Infants ages -13 years that had HPS in infancy

Measure	Description	Time Frame
Increased sodium intake		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ayala Maayan-Metzger, Dr.	Contact	972-54-6278248

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D046248	Pyloric Stenosis, Hypertrophic

Ancestor Terms

ID	Term
D011707	Pyloric Stenosis
D017219	Gastric Outlet Obstruction
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided