Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

Brief Summary

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”

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 Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: October 2012

Outcome Measures for this Clinical Trial

Primary Measures

  • Assess the ability of IHM to measure changes of hydration status ni newborn and infants
    • Time Frame: 1 week to several months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 3 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Artann Laboratories
  • Collaborator
    • Bill and Melinda Gates Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dace Gardovska, Dr. Med., Principal Investigator, Head of Pediatrics, CCUH RSU


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