Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

Diarrhea Clinical Trial

— IHM-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482208
• Other study ID #: IHM-01
• Secondary ID: Gates Foundation
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: March 28, 2014
• Start date: November 2011
• Est. completion date: October 2012

Study information

• Verified date: March 2014
• Source: Artann Laboratories
• Contact: n/a
• Is FDA regulated: No
• Health authority: Latvia: Internal Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dehydration
• Diarrhea

Locations

Country	Name	City	State
Latvia	Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)	Riga

Sponsors (2)

Lead Sponsor	Collaborator
Artann Laboratories	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the ability of IHM to measure changes of hydration status ni newborn and infants	Infants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible	1 week to several months	No

External Links

•   Bill and Melinda Gates Foundation
•   Sponsor Link to Reference #9