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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
Montpellier and Pessac, FranceSee the 2 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

Where in France

  • CHU de Montpellier - Hôpital Arnaud de VilleneuveMontpellier, FranceContact: Marie VINCENTI, MDNo longer taking part
  • CHU de Bordeaux Hopital Cardiologique Haut-LevequePessac, FranceContact: Mélissa DACCORDNo longer taking part

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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