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

N/ANot Yet RecruitingNCT06998290

University Hospital, Bordeaux20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

CHD - Congenital Heart Disease

Blue-Line home telemonitoring programOTHER

* A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform

Eligibility

Sex: ALLMin age: 0 MonthsMax age: 12 Months

Medical Language ↔ Plain English

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

Locations (2)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France, France

CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

Pessac, France, France

Outcomes

Primary Outcomes

Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered

Contributes to programme feasibility criteria