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Clinical Trials in France / NCT06998290
Starting soon Not applicable

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life

NCT06998290 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2025-06-01
Last updated
2025-05-31

Condition(s) studied

CHD - Congenital Heart Disease

Investigational drug(s) / intervention(s)

Blue-Line home telemonitoring program

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

Study 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.

Eligibility

Sex
ALL
Min age
0 Months
Max age
12 Months
Healthy volunteers
No
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 outcome measure(s)

  • Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Evaluation of the measurement devices: functional (yes/no) — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Evaluation of the telemonitoring platform (functional/ergonomic/reliable) — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Recruitment rate: number of participants out of number of eligible patients — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Acceptability to parents: parent satisfaction questionnaire — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria
  • Acceptability to caregivers: caregiver satisfaction questionnaire — between inclusion visit and the last protocol visit (month 12)
    Contributes to programme feasibility criteria

Trial sites (2)

FacilityCityRegionStatus
CHU de Montpellier - Hôpital Arnaud de Villeneuve Montpellier France
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque Pessac France

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Other trials for the same condition

Ultrafast Ultrasound Imaging in Pediatric Cardiology Recruiting
Brain Ultrafast Ultrasound Imaging Starting soon
Home-based Cardiovascular Rehabilitation in Young Patients With Congenital Heart Disease: the "Muscle Your Heart" Program Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06998290 on ClinicalTrials.gov ↗ ← All trials in France