About this trial
Actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. This is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. The aim of the study is to assess the feasibility and acceptability of monitoring newborns and infants with congenital heart disease awaiting cardiac surgery using the Blue-Line home telemonitoring program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newborns and/or infants aged 0 to 12 months inclusive at the time of diagnosis.
With congenital heart disease as defined in the ICD-11 classification.
Waiting for an intervention by cardiac surgery or interventional catheterization.
Free, informed consent signed by the holder(s) of parental authority.
Disqualifiers
Short-term vital prognosis
Clinical situation identified at the M3C RCP that contraindicates a return home
Family situation identified at the M3C RCP as contra-indicating a return home
Extra-cardiac co-morbidities requiring hospitalisation independent of the heart disease (e.g. severe renal failure, neurological deficit, complex immune deficiency, etc.).
Trial design
Single group
Treatments tested in this trial
Blue-Line home telemonitoring program
Other intervention* A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered
Contributes to programme feasibility criteria
Evaluation of the measurement devices: functional (yes/no)
Contributes to programme feasibility criteria
Evaluation of the telemonitoring platform (functional/ergonomic/reliable)
Contributes to programme feasibility criteria
Recruitment rate: number of participants out of number of eligible patients
Contributes to programme feasibility criteria
Secondary outcomes
Events of interest
Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation.
Date of telemonitoring alert
Contributes to the alert performance criteria
Severity level of alert (orange/red)
Contributes to the alert performance criteria
Appropriateness of the alert (yes/no)
Contributes to the alert performance criteria
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: