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Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

Study of Ultrasonic Hydration Monitor for Neonatology and Pediatric Children and Infants and/or Children up to Age 3 Years Old With Diarrhea

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01482208
Acronym
IHM-01
Enrollment
42
Registered
2011-11-30
Start date
2011-11-30
Completion date
2012-10-31
Last updated
2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dehydration, Diarrhea

Keywords

Dehydration, Hydration, Muscle composition, Diarrhea, Pediatrics, Neonatology, Ultrasound

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.

Interventions

None listed

Sponsors

Bill and Melinda Gates Foundation
CollaboratorOTHER
Artann Laboratories
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Assess the ability of IHM to measure changes of hydration status ni newborn and infants1 week to several monthsInfants and small children diagnosed with diarrhea or presenting to the hopsital with diseases known to cause dehydration are eligible

Countries

Latvia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026