Hydration Status Evaluation of Dehydrated Children With Experimental Devices



Status:Enrolling by invitation
Healthy:No
Age Range:2 - 18
Updated:12/7/2018
Start Date:November 2016
End Date:December 2019

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Hydration Status Evaluation on Admittance and During Rehydration of Dehydrated Children at Boston Children's Hospital, With Exploratory Hydration Assessment Devices

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.

This is a prospective cohort study to determine the performance of two prototype devices
developed to aid in the diagnosis and monitoring of physiological hydration state of
dehydrated children. These children are patients presenting to the emergency department with
varying degrees of dehydration.

Overview of study procedure:

1. Initial identification of eligible patients. Patients will be initially identified by
their chief complaint after registration and triage. Terms such as "Dehydration",
"Gastroenteritis", "Diarrhea", "Vomiting", and or "Intolerance of POs" will be noted and
those patients will be approached by study personnel for possible participation in the
study.

2. Screening and obtaining of consent After patients have been identified as meeting entry
criteria for the study, the parents will be asked two screening questions: 1. How far of
a distance do you live from the hospital? 2. Would you be interested in a study that
includes a follow-up home visit? These questions will be used to gauge the ability of
the family to realistically complete the study, as a research coordinator will be
travelling to the home to conduct a follow up visit after symptom resolution.

3. Study enrollment i. Risks and benefits of study participation will be discussed, as well
as the consent process. After consent is obtained, a symptom survey will be administered
to each patient and family to determine the degree of dehydration based on clinical
assessment. Detailed information regarding onset and degree of symptoms including
vomiting, diarrhea, urine output and amount of oral fluid intake will be recorded. A
similar survey was administered as part of a randomized control trial of Dextrose
containing fluids, which was conducted in our Emergency Department, (Levy, Waltzman).

ii. Each patient will have his/her weight obtained using a calibrated digital scale in a
dry diaper or underwear with an appropriately sized gown. Then both study devices will
be utilized by study personnel to obtain three triplicate measurements. Replicate
measurements of capillary refill times will also be obtained in the same locations by
visual inspection using a commercial stopwatch. Additional information including ambient
room temperature, patient skin temperature and amount of applied pressure during the
Capillary Refill Time measurements will be recorded.

iii. After the initial measurements are obtained, the treating provider will be given a
questionnaire outlining their assessment of the degree of dehydration of the patient and
the study protocol. Patients will be treated per the discretion of the health care
provider including admission to the hospital or discharge based on his or her clinical
judgment. Device measurements will not be provided to the treating clinician.
Measurements obtained from the device will have no bearing on the clinical treatment of
the patients. All measurements obtained in relation to the study will be used solely for
research purposes. Device measurements of capillary refill time and radio-frequency
measurements, and initial weight will not be disclosed to treating staff.

iv. Prior to either discharge from the emergency department or admission to the
hospital, each participating family will be given a symptom log to serve as a method for
objectively tracking degree of symptoms during the follow up period.

4. Initial follow up and monitoring of symptom resolution:

A research coordinator will call each patient's family by phone within 24-72 hours after
initial enrollment. He or she will establish contact with the family and explain the
follow up plan and monitoring for symptom resolution. Regular follow up by phone every
48 hours will continue until the symptoms have resolved; at which time an in-person
follow up visit will be planned within 24-72 hours.

5. In-person follow-up After the resolution of symptoms (vomiting and/or diarrhea), the
research coordinator will travel to the residence of each patient and repeat the
measurements including weight and device measurements. Again the weight will be
performed on a calibrated digital scale with the patient in a dry diaper or underwear
and an appropriately sized gown. Also, the study coordinator will ask the family/patient
to answer questions related to the duration of the illness, and other visits with
medical providers that have occurred in the interim. The radio-frequency and capillary
refill time measurements will be stored in a secure de-identified server, and all
remaining data will be recorded entered into a password-protected digital database using
RedCap.

Inclusion Criteria:

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

Exclusion Criteria:

1. Previously enrolled in this study

2. 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
We found this trial at
2
sites
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Cambridge, Massachusetts 02139
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