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

Artann Laboratories

Status: Completed

Conditions: Dehydration; Diarrhea

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01482208

IHM-01

Gates Foundation (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 1 day to 3 years old

Volunteers: Accepts Healthy Volunteers

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