Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Diarrhea Dehydration

Keywords

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Dehydration Hydration Muscle composition Diarrhea Pediatrics Neonatology Ultrasound

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dace Gardovska, Dr. Med.

Role: PRINCIPAL_INVESTIGATOR

Head of Pediatrics, CCUH RSU

Locations

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

Riga, , Latvia

Site Status

Countries

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Latvia

Other Identifiers

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Gates Foundation

Identifier Type: OTHER

Identifier Source: secondary_id

IHM-01

Identifier Type: -

Identifier Source: org_study_id