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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Artann Laboratories
ClinicalTrials.gov Identifier:
NCT01482208
First received: November 28, 2011
Last updated: October 11, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition
Diarrhea
Dehydration

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea

Resource links provided by NLM:

MedlinePlus related topics: Dehydration Diarrhea
U.S. FDA Resources

Further study details as provided by Artann Laboratories:

Primary Outcome Measures:
  • Assess the ability of IHM to measure changes of hydration status ni newborn and infants [ Time Frame: 1 week to several months ] [ Designated as safety issue: No ]
    Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible


Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482208

Locations
Latvia
Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)
Riga, Latvia, LV-1004
Sponsors and Collaborators
Artann Laboratories
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Dace Gardovska, Dr. Med. Head of Pediatrics, CCUH RSU
  More Information

Additional Information:
Sponsor Link to Reference #9  This link exits the ClinicalTrials.gov site
Bill and Melinda Gates Foundation  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Artann Laboratories
ClinicalTrials.gov Identifier: NCT01482208     History of Changes
Other Study ID Numbers: IHM-01, Gates Foundation
Study First Received: November 28, 2011
Last Updated: October 11, 2012
Health Authority: Latvia: Internal Review Board

Keywords provided by Artann Laboratories:
Dehydration
Hydration
Muscle composition
Diarrhea
 Pediatrics
Neonatology
Ultrasound

Additional relevant MeSH terms:
Dehydration
Diarrhea
Water-Electrolyte Imbalance
Metabolic Diseases
 Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013