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

NCT06998290 | Not Yet Recruiting

• 2 other identifiers: CHUBX 2021/412024-A01759-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

CHD - Congenital Heart Disease

Keywords

Congenital heart disease; Infants; Vulnerability; Home monitoring; Therapeutic education; Digital platform

Outcome Measures

Primary Outcomes (7)

• 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

  between inclusion visit and the last protocol visit (month 12)

• Evaluation of the measurement devices: functional (yes/no)

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

• Evaluation of the telemonitoring platform (functional/ergonomic/reliable)

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

• Recruitment rate: number of participants out of number of eligible patients

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

• Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

• Acceptability to parents: parent satisfaction questionnaire

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

• Acceptability to caregivers: caregiver satisfaction questionnaire

  Contributes to programme feasibility criteria

  between inclusion visit and the last protocol visit (month 12)

Secondary Outcomes (12)

• Events of interest

  between months 3 and 12

• Date of telemonitoring alert

  between months 3 and 12

• Severity level of alert (orange/red)

  between months 3 and 12

• Appropriateness of the alert (yes/no)

  between months 3 and 12

• Respect for the procedure to be followed following an alert by parents (yes/no)

  between months 3 and 12

Study Arms (1)

Blue-Line programme

EXPERIMENTAL

Telemonitoring program

Other: Blue-Line home telemonitoring program

Interventions

Blue-Line home telemonitoring program 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

Blue-Line programme

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France, 34295 - Cedex 5, France

Location

CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque

Pessac, France, 33604, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mélissa DACCORD

CONTACT

+33 5 24 54 91 68; melissa.daccord@chu-bordeaux.fr

Julie CHABANEIX, MD

CONTACT

+33 5 57 65 61 09; julie.thomas@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

FR (2)