NCT01159509

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

10 months

First QC Date

July 8, 2010

Last Update Submit

July 8, 2010

Conditions

Keywords

hypertrophic pyloric stenosissodium intakeHealthy children with no chronic diseasesStatus post HPS

Outcome Measures

Primary Outcomes (1)

  • Increased sodium intake

    1 year

Study Arms (1)

Infants ages -13 years that had HPS in infancy

Behavioral: sodium taste tests

Interventions

The cohort group will had sodium taste tests and an interview regarding diat habits.

Infants ages -13 years that had HPS in infancy

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Children with chronic diseases
  • Hospitalization due to dehydration after HPS hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pyloric Stenosis, Hypertrophic

Condition Hierarchy (Ancestors)

Pyloric StenosisGastric Outlet ObstructionStomach DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Ayala Maayan-Metzger, Dr.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 9, 2010

Record last verified: 2010-07