Status:
COMPLETED
Clinical Evaluation of Ultrasonic Hydration Monitor for Infants
Lead Sponsor:
Artann Laboratories
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Diarrhea
Dehydration
Eligibility:
All Genders
1-3 years
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01482208
Start Date
November 1 2011
End Date
October 1 2012
Last Update
March 31 2014
Active Locations (1)
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1
Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)
Riga, Latvia, LV-1004