Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies

Neutropenia, secondary to myelosupressive therapies, predisposes patients to significant risk
for infectious complications which increases morbidity and mortality. Usually, fever is the
first clinical sign of the inflammatory response to the infective process; and early
detection is an indication for empiric antimicrobial therapy and further evaluation to
determine risk for sepsis. Today, broad-spectrum antimicrobial therapy at the first detection
of fever has helped significantly decreased the mortality associated with neutropenia in the
intensive phase of chemotherapy. Therefore, early detection of fever, through regular
temperature monitoring, in a neutropenic patient is critical to improved clinical outcome.
Vigilance on the part of care providers and care givers is crucial to early detection.
Traditionally, this is simply done through episodic oral or axillary monitoring of
temperature. In this study, we propose to test the use feasibility of an innovative device
that continuously monitors body temperature as a clinical decision support tool in pediatric
patients undergoing myelosuppressive therapies for acute leukemias and other childhood
cancers.

The iThermonitor, a FDA class II device, is a high accuracy device that continuously monitors
body temperature and connects to a receiver (iPad mini) via bluetooth to display body
temperature data in real time. The iThermonitor is attached to the skin by a hydrogel
dressing which can be changed as needed. It captures data even without connection to a
receiver and it can establish connection to a paired receiver device (the iPad mini) within a
range of three meters. The provided iPad mini will be pre-loaded with the iThermonitor app
which will be used to pair the receiver with the iThermonitor device. The device monitors
body temperature every four seconds and is able to store 10 days worth of data that can be
offloaded as soon as it establishes connection with a receiver. It is able to measure
temperature in the range of 25-45 degrees Celsius. Users are able to set temperature limits
at which alerts for which out-of-range temperature can go off. It also provides care
providers an opportunity to remotely monitor their patients' temperature in the immediate
period after discharge from the hospital. Therefore, we hypothesize that the iThermonitor can
serve as a feasible clinical decision support in the management of pediatric patients
undergoing intensive treatments for acute leukemia and other childhood cancers.

This study will be implemented as a pilot study to test the use feasibility of the
iThermonitor as a clinical decision support for continuous temperature monitoring in a dyad
of 25 pediatrics patients, (aged 2yrs - 17yrs) on myelosuppressive therapies for acute
leukemia and other childhood cancers at the MGH Pediatric Hematology and Oncology group, and
their caregivers. The iThermonitor will be used by patients and their caregivers at home over
a 2-week study period starting from the day after chemotherapy. There will be two study
visits: study enrollment and study closeout.

The investigators have chosen to implement this study as a feasibility study because the
investigators' goal is to determine if continuous temperature monitoring by the iThermonitor
can work in home settings. To the investigators' knowledge, the researchers are not aware of
any previous research exploring continuous temperature monitoring in pediatric oncology
patients on myelosuppresive therapies. Therefore, findings from this study have the potential
to advance knowledge about the management of fever in pediatric patients on myelosuppresive
therapies.

Inclusion Criteria:

- Dyad consists of a pediatric patient aged 2-17 years undergoing myelosuppressive
therapies for acute leukemias and other childhood cancers.

- Dyad also includes a caregiver, ≥ 18 years of age that is willing to participate in
the study.

- Ability of caregiver or patient (if old enough) to read and speak English.

- If applicable, willingness of the patient to shave axillary (armpit) hair.

- Caregiver (parent or legal guardian) must give informed consent for dyad
participation.

Exclusion Criteria:

- Patient has a history of allergy to hydrogel dressing or ongoing skin diseases

- Patients with ongoing febrile illness or documented infectious disease.