Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life (Blue-Line)

University Hospital of Bordeaux

Status

Not yet enrolling

Conditions

CHD - Congenital Heart Disease

Treatments

Other: Blue-Line home telemonitoring program

Study type

Interventional

Funder types

Other

Identifiers

NCT06998290

2024-A01759-38 (Other Identifier)

CHUBX 2021/41

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

Under 12 months old

Volunteers

No Healthy Volunteers

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