Clinical Evaluation of Ultrasonic Hydration Monitor for Infants (IHM-01)

March 28, 2014 updated by: Artann Laboratories

Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea

Study will verify ability of infant Hydration Monitor (IHM) to assess changes of hydration status in newborns and infants by means of ultrasound velocity measurements through muscle tissues. Changes of tissue hydration will be followed during first days of life in newborns and in acute diarrhea in small children during re-hydration therapy. Weighting and clinical dehydration symptoms will be used as controls.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

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

Study Locations

  • Latvia
      • Riga, Latvia, LV-1004
        • Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)

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

1 day to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns from 1 to 7 days Small children from 1 month to 3 years old

Description

Inclusion Criteria:

  • Newborns from 1 to 7 days old,
  • Health infants from 1 month to 3 years old,
  • Any ethnicity,
  • Male or female,
  • Infants with diarrhea,
  • Acute gastroenteritis,
  • Diarrhea and/or vomiting,
  • Suspected dehydration

Exclusion Criteria:

  • Congenital heart disease,
  • Renal failure,
  • Chronic liver disease,
  • Chronic lung disease,
  • Inflammatory bowel disease,
  • Immune deficiency,
  • Severe malnutrition,
  • Any external damage to skin of leg,
  • Infants and Children whose parents refuse permission to be included

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-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the ability of IHM to measure changes of hydration status ni newborn and infants
Time Frame: 1 week to several months
Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible
1 week to several months

Collaborators and Investigators

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

Sponsor

Artann Laboratories

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Dace Gardovska, Dr. Med., Head of Pediatrics, CCUH RSU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

November 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

November 29, 2011

First Posted (Estimate)

November 30, 2011

Study Record Updates

Last Update Posted (Estimate)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 28, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHM-01
  • Gates Foundation (Other Identifier: Bill and Melinda Gates Foundation Round 6)

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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