Hydration Status Evaluation of Dehydrated Children With Experimental Devices

Summary

A pediatric study in collaboration with Boston Children's Hospital to review the performance of two novel hydration status measurement devices against standard clinical assessment methods, through repeated measurement of hydration status of dehydrated children admitted to the emergency department receiving rehydration therapy, followed by an at-home follow-up measurement once symptoms have resolved.

Conditions

• Dehydration

Interventions

OTHER

Formalized clinical assessment of hydration status

Undertake and record a standard formalized clinical hydration assessment

OTHER

Take a measurement of body weight on calibrated scales

Standard body weight measurements conducted on calibrated scales

DEVICE

"RF wristband" hydration status measurement

Take measurements with "RF wristband" radio-frequency non-invasive wrist-based hydration status assessment device

OTHER

Measure capillary refill time with manual stopwatch

A standard visual assessment of capillary refill time, aided by the use of a stopwatch

DEVICE

"CRT device" hydration status measurement

Take measurements with "CRT device" for non-invasively quantitatively assessing Capillary Refill Time

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute for Biomedical Imaging and Bioengineering (NIBIB)

  collaborator NIH

• Massachusetts Institute of Technology

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2019-04-30

Completion

2019-04-30

Countries

• United States

Study Locations