NCT01482208
Completed
Not Applicable
Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea
Artann Laboratories1 site in 1 country42 target enrollmentNovember 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diarrhea
- Sponsor
- Artann Laboratories
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Assess the ability of IHM to measure changes of hydration status ni newborn and infants
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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
Study Sites (1)
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