NCT00931177

Brief Summary

This is a study to evaluate the validity, reliability, and clinical usefulness of a new dehydration scoring system (DSS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 5, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

July 1, 2009

Last Update Submit

September 2, 2011

Conditions

Dehydration

Outcome Measures

Primary Outcomes (1)

  • Change in weight compared to dehydration score.

    1 week

Study Arms (1)

Dehydrated children

children with dehydration

Other: weightOther: weight and dehydration score

Interventions

weightOTHER

weight and dehydration scores

Dehydrated children
weight and dehydration scoreOTHER

weight and dehydration score

Also known as: weight and dehydration
Dehydrated children

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Dehydrated children

You may qualify if:

  • mo - 15 yo children with DEHYDRATION from vomiting, diarrhea, or poor oral intake from presumed gastroenteritis
  • Previously healthy

You may not qualify if:

  • Preexisting cardiac, renal, or gastrointestinal disease
  • diabetes
  • failure to thrive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85029, United States

Location

Related Publications (1)

  • Practice parameter: the management of acute gastroenteritis in young children. American Academy of Pediatrics, Provisional Committee on Quality Improvement, Subcommittee on Acute Gastroenteritis. Pediatrics. 1996 Mar;97(3):424-35.

    PMID: 8604285BACKGROUND

MeSH Terms

Conditions

Dehydration

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Mark Hostetler, MD

    Phoenix Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 2, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

November 1, 2010

Last Updated

September 5, 2011

Record last verified: 2011-09

Locations

US(1)