Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

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.

Completed

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Key information

Conditions

Diarrhea Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Water-Electrolyte Imbalance

Age range

1 day–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)

Riga, LV-1004, Latvia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Assess the ability of IHM to measure changes of hydration status ni newborn and infants

Time frame: 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

Sponsors and collaborators

Lead sponsor

Artann Laboratories

Industry

Collaborators

Bill and Melinda Gates Foundation

Registry information

Official study title

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

Acronym: IHM-01

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Nov 30, 2011
Registry last updated: Mar 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed