Hydration Status Evaluation of Dehydrated Children With Experimental Devices

NCT02960789 | Completed

• 2 other identifiers: 1606619184U54EB015408
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Dehydration; Children; Measurement

Outcome Measures

Primary Outcomes (3)

• Change in body weight (Weight at follow-up visit minus weight in emergency department)

  1-14 days

• Change in capillary refill time as measured by experimental measurement device 1.

  1-14 days

• Change in wrist water content as measured by experimental measurement device 2.

  1-14 days

Study Arms (1)

Dehydrated Children

EXPERIMENTAL

Children between the ages of 2 to 18 years of age presenting to the Emergency Department at Children's Hospital Boston with complaints such as "Dehydration", "Gastroenteritis", "Vomiting", and or "Intolerance of POs" be approached by study personnel for possible participation in the study. Interventions: * Undertake and record a formalized clinical assessment of hydration status * Take a measurement of body weight on calibrated scales * "RF wristband" hydration status measurement * Measure capillary refill time with manual stopwatch * "CRT device" hydration status measurement

Other: Formalized clinical assessment of hydration status; Other: Take a measurement of body weight on calibrated scales; Device: "RF wristband" hydration status measurement; Other: Measure capillary refill time with manual stopwatch; Device: "CRT device" hydration status measurement

Interventions

Formalized clinical assessment of hydration status OTHER

Undertake and record a standard formalized clinical hydration assessment

Dehydrated Children

Take a measurement of body weight on calibrated scales OTHER

Standard body weight measurements conducted on calibrated scales

Dehydrated Children

"RF wristband" hydration status measurement DEVICE

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

Dehydrated Children

Measure capillary refill time with manual stopwatch OTHER

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

Dehydrated Children

"CRT device" hydration status measurement DEVICE

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

Dehydrated Children

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Dehydrated children, indicated primarily by chief complaints or symptoms of vomiting, diarrhea, dehydration, gastroenteritis or intolerance of oral intake for less than or equal to 5 days

You may not qualify if:

• Previously enrolled in this study
• Children with a pre-existing medical condition which may potentially affect either the course or nature of their current illness, or a skin condition which has the potential to alter their capillary refill time, specifically:
• a. Pre-existing medical conditions i. Immunosuppression (HIV, malignancy) ii. Existing gastrointestinal condition (Inflammatory bowel disease, Crohns disease, ulcerative colitis, or recent abdominal surgery within prior 30 days) iii. Uncorrected or palliated cardiac disease iv. Other chronic medical condition other than asthma or eczema (such as cystic fibrosis, diabetes, or patients with an indwelling devices such as gastrostomy, nasogastric or nasojejunal tube, or ventriculoperitoneal shunts
• b. Concern for surgical abdomen i. Abdominal trauma or head trauma as reason for visit ii. Potential surgical condition (concern for appendicitis, intussusception, malrotation, volvulus, bowel obstruction)
• c. Skin condition which may alter optical and radio-frequency measurements, or cause discomfort i. Acanthosis ii. Severe eczema covering all exposed testing sites to measure capillary refill iii. Burns

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead
• Boston Children's Hospital: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 10, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 20, 2020

Record last verified: 2018-12

Locations

US (2)