Heart failure is a complex clinical syndrome, representing the final evolution of many cardiac diseases that may differ for etiology and pathophysiology. In pediatric population, it is particularly challenging to manage because of the heterogeneity in age, primary cardiac disease, and the broad range of clinical signs and symptoms. Frequent hospitalizations are current problem. Hospitalization within the first year since the first episode, lack of adherence to medical therapy and diet difficulties are the main issues in this population of patients, and they rebounds on prognosis and public health costs. Actions aimed to prevent and manage these matters will improve outcome in patients with chronic heart failure. Telemedicine proved its usefulness in adult population, but, nowadays, no studies have been conducted in children. From the beginning of 21th century, remote monitoring attempts have been adopted, initially by phone calls. Currently, the e-care monitoring fits in the context of telemedicine 2.0 based on new communication models. The aim of this study is to affirm the feasibility and efficacy of a new model of tele monitoring in pediatric population. High-risk patients need a strict clinical control normally difficult to adopt. A telematics system capable to detect vital parameters as heart rate, body temperature, blood pressure, oxygen saturation, breathe frequency, weight, arrhythmias and cardiac index may offers to physician valuable information able to strictly monitoring the clinical status of patients. All of these data permits to physician to early detect critical signals of a deteriorated status, modify adherence to care and implement therapeutic strategies in order to prevent frequent hospitalizations. Our project provides a system of continuous tele-monitoring of vital parameters through a patch applied on the chest of the baby. Data are sent to a service center, "virtual clinic" and daily analyzed in multiparametric system by a specialized nurse. On the basis of pre-established alarms, the virtual clinic will notify to physician. Feasibility and tolerability of this new monitoring system will be evaluated after a 3 months period on a cohort of 20 patients affected by chronic, high-risk, heart failure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
Telemonitoring for pediatric heart failure
Bambino Gesù Hospital
Rome, Italy
Primary outcome
number of day (percentage) of adherence to telemonitoring, at least 18 hours per day when the patient kept the patch applied at 3 months.
Time frame: three months
Number of hours of patch kept applied
Tolerability
Time frame: at 1 week
Number of hours of patch kept applied
Tolerability
Time frame: at 3 months
Interquartile Range - median of hours of patch kept applied
Tolerability
Time frame: at 1 week
Interquartile Range - median of hours of patch kept applied
Tolerability
Time frame: at 3 months
Number of unplanned hospitalization
Reliability
Time frame: 3 months
Number of life treating arrhythmias
Reliability
Time frame: 3 months
Mortality
Reliability
Time frame: 3 months
Number of unplanned hospital access (day hospital / ambulatory)
Reliability
Time frame: 3 months
Comparison to levels of Hemoglobin (g/dL)
Reliability
Time frame: 3 months
Comparison to levels of Albumin (g/dL)
Reliability
Time frame: 3 months
Comparison to levels of Sodium (mEq/L)
Reliability
Time frame: 3 months
Comparison to levels of Potassium (mEq/L)
Reliability
Time frame: 3 months
Comparison to levels of Serum Creatinine (mg/dL)
Reliability
Time frame: 3 months
Satisfaction questionnaire
Satisfaction
Time frame: 1 week
Satisfaction questionnaire
Satisfaction
Time frame: 3 months
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