Not yet recruitingNo phase
Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life
Key facts
- Who runs it
- University Hospital, Bordeaux
- Where
- France2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 20 people, planned
- Started
- 1 Jun 2025
- Expected to end
- 1 Jun 2027
- Type of study
- Interventional
- Treatments tested
- Blue-Line home telemonitoring program
- Record updated
- 31 May 2025
Who can take part
- Age
- 0 months to 12 months
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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)
- 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
- Parents unable to give informed consent
- Minors with parental authority
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- Blue-Line programmeTreatment being tested
Telemonitoring program
Treatment: Blue-Line home telemonitoring program
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 31 May 2025