Hydration Status Evaluation of Dehydrated Children With Experimental Devices
Completed · Not applicable
Conditions studied: Dehydration
In brief
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.
Key facts
- Study ID
- NCT02960789
- Run by
- Massachusetts Institute of Technology
- People needed
- 137
- Starts
- 2016-11-01
- Expected to finish
- 2019-04-01
- Last updated by the study team
- 2020-03-20
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
- Massachusetts Institute of Technology — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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