Clinical Evaluation of Ultrasonic Hydration Monitor for I... | NCT01482208

Studies
Clinical Evaluation of Ultrasonic Hydration Monitor for Infants

NCT01482208

Sponsor

Artann Laboratories

Status

Completed

Last Update Posted

Mar 31, 2014Estimated

Enrollment

42Actual

Phase

Not provided

Conditions

Diarrhea
Dehydration

Interventions

Not provided

Countries

Latvia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Gates Foundation	Other Identifier	Bill and Melinda Gates Foundation Round 6

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

Nov 28, 2011

First Submission Date that Met QC Criteria

Nov 29, 2011

First Posted Date

Nov 30, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2014

Last Update Posted Date

Mar 31, 2014Estimated

Name	Class
Bill and Melinda Gates Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

3 Years

Standard Ages

Child

Study Population

Newborns from 1 to 7 days Small children from 1 month to 3 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dace Gardovska, Dr. Med.	Head of Pediatrics, CCUH RSU	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children Clinical University Hospital (CCUH) of the Riga Stradinsh University (RSU)		Riga		LV-1004	Latvia

Label	URL
Sponsor Link to Reference #9	View source

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea
D003681	Dehydration

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D014883	Water-Electrolyte Imbalance

Browse Leaves

Not provided

Browse Branches

Not provided