Clinical Evaluation of Ultrasonic Hydration Monitor for Infants
Completed
- Conditions
- DiarrheaDehydration
- Registration Number
- NCT01482208
- Lead Sponsor
- Artann Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assess the ability of IHM to measure changes of hydration status ni newborn and infants 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)
🇱🇻Riga, Latvia