Clinical trial NCT06998290: Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life
Official title: Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: CHD - Congenital Heart Disease
Keywords: Congenital heart disease
Infants
Vulnerability
Home monitoring
Therapeutic education
Digital platform
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Person affiliated to or benefiting from a social security scheme.

Exclusion Criteria:

* 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.).
* Limited understanding of parental authority holder(s) / caregivers (non-French speaking, hearing impaired, cognitive impairment or other)
* Parents unable to give informed consent.
* Minors with parental authority

Primary outcomes:
measure: Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Evaluation of the measurement devices: functional (yes/no)
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Evaluation of the telemonitoring platform (functional/ergonomic/reliable)
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Recruitment rate: number of participants out of number of eligible patients
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Acceptability to parents: parent satisfaction questionnaire
timeFrame: between inclusion visit and the last protocol visit (month 12)
measure: Acceptability to caregivers: caregiver satisfaction questionnaire
timeFrame: between inclusion visit and the last protocol visit (month 12)
Secondary outcomes:
measure: Events of interest
timeFrame: between months 3 and 12
measure: Date of telemonitoring alert
timeFrame: between months 3 and 12
measure: Severity level of alert (orange/red)
timeFrame: between months 3 and 12
measure: Appropriateness of the alert (yes/no)
timeFrame: between months 3 and 12
measure: Respect for the procedure to be followed following an alert by parents (yes/no)
timeFrame: between months 3 and 12
measure: Appropriateness of medical management following the alert given the clinical situation (yes/no)
timeFrame: between months 3 and 12
measure: Evolution of the height (cm)
timeFrame: between months 2 and 12
measure: Evolution of the weight (kg)
timeFrame: between months 2 and 12
measure: Evolution of oxygen saturation (SpO2, %)
timeFrame: between months 2 and 12
measure: Evolution of the heart failure score (Ross classification)
timeFrame: between months 2 and 12
measure: Life quality
timeFrame: between months 2 and 12
measure: Parental anxiety
timeFrame: between months 2 and 12
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
Study officials:
References: