An interventional study of Blue-Line home telemonitoring program in CHD - Congenital Heart Disease, sponsored by University Hospital, Bordeaux. Not yet recruiting at 2 sites in France. Open to participants aged 0 Months to 12 Months. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Other
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.
Today, congenital heart disease affects around 0.8% of births in France. One third of children diagnosed antenatally or postnatally with congenital heart disease will require surgical or percutaneous intervention within the first year of life. 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. Our research team at the M3C Network Reference Center aims to develop home telemonitoring for these patients, in order to innovate and optimize their care pathway.
1,031 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 531 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Telemonitoring program
Other: Blue-Line home telemonitoring program
* A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform
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
Time frame: between inclusion visit and the last protocol visit (month 12)
Evaluation of the measurement devices: functional (yes/no)
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Evaluation of the telemonitoring platform (functional/ergonomic/reliable)
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Recruitment rate: number of participants out of number of eligible patients
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Acceptability to parents: parent satisfaction questionnaire
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Acceptability to caregivers: caregiver satisfaction questionnaire
Contributes to programme feasibility criteria
Time frame: between inclusion visit and the last protocol visit (month 12)
Events of interest
Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation.
Time frame: between months 3 and 12
Date of telemonitoring alert
Contributes to the alert performance criteria
Time frame: between months 3 and 12
Severity level of alert (orange/red)
Contributes to the alert performance criteria
Time frame: between months 3 and 12
Appropriateness of the alert (yes/no)
Contributes to the alert performance criteria
Time frame: between months 3 and 12
Respect for the procedure to be followed following an alert by parents (yes/no)
Contributes to the alert performance criteria
Time frame: between months 3 and 12
Appropriateness of medical management following the alert given the clinical situation (yes/no)
Contributes to the alert performance criteria
Time frame: between months 3 and 12
Evolution of the height (cm)
Contributes to the clinical evolution criteria
Time frame: between months 2 and 12
Evolution of the weight (kg)
Contributes to the clinical evolution criteria
Time frame: between months 2 and 12
Evolution of oxygen saturation (SpO2, %)
Contributes to the clinical evolution criteria
Time frame: between months 2 and 12
Evolution of the heart failure score (Ross classification)
Contributes to the clinical evolution criteria
Time frame: between months 2 and 12
Life quality
Changes in the score of the QUALIN (QUALIté de vie du Nourrisson) validated generic quality of life proxy questionnaire: before returning home, at 3 months and at the end of the programme. The QUALIN questionnaire is a 34-item generic French QoL instrument designed for infants (aged 0-3 years). Each answer scores from -2 (totally false) to +2 (quite true). An item with a score \>1 corresponds to favourable QoL.
Time frame: between months 2 and 12
Parental anxiety
Changes in the score of the STAI (State-Trait Anwiety Inventory) parental anxiety questionnaire: state-trait anxiety inventory. The STAI questionnaire is a 40-item instrument designed for adults. Each answer score from 1 to 4. The higher the score, the less anxious the patient.
Time frame: between months 2 and 12
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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