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

NCT ID: NCT06998290

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2027-06-01

Brief 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.

Detailed 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.

Conditions

CHD - Congenital Heart Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Blue-Line programme

Telemonitoring program

Group Type: EXPERIMENTAL

Blue-Line home telemonitoring program

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France, France

CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

Pessac, France, France

Countries

France

Central Contacts

Mélissa DACCORD

Role: CONTACT

melissa.daccord@chu-bordeaux.fr

+33 5 24 54 91 68 ext. +33

Julie CHABANEIX, MD

Role: CONTACT

julie.thomas@chu-bordeaux.fr

+33 5 57 65 61 09 ext. +33

Facility Contacts

Marie VINCENTI, MD

Role: primary

m-vincenti@chu-montpellier.fr

+33 4 67 33 66 43 ext. +33

Mélissa DACCORD

Role: primary

melissa.daccord@chu-bordeaux.fr

+33 5 24 54 91 68

Other Identifiers

2024-A01759-38

Identifier Type: OTHER

Identifier Source: secondary_id

CHUBX 2021/41

Identifier Type: -

Identifier Source: org_study_id