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NCT Number: NCT06998290

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During 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. 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.

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Key information

Conditions

CHD - Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier - Hôpital Arnaud de Villeneuve, Montpellier, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

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

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

  3. Evaluation of the telemonitoring platform (functional/ergonomic/reliable)

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

  4. Recruitment rate: number of participants out of number of eligible patients

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

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

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

  6. Acceptability to parents: parent satisfaction questionnaire

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

  7. Acceptability to caregivers: caregiver satisfaction questionnaire

    Time frame: between inclusion visit and the last protocol visit (month 12)

    Contributes to programme feasibility criteria

Secondary outcomes

  1. Events of interest

    Time frame: between months 3 and 12

    Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation.

  2. Date of telemonitoring alert

    Time frame: between months 3 and 12

    Contributes to the alert performance criteria

  3. Severity level of alert (orange/red)

    Time frame: between months 3 and 12

    Contributes to the alert performance criteria

  4. Appropriateness of the alert (yes/no)

    Time frame: between months 3 and 12

    Contributes to the alert performance criteria

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

    Time frame: between months 3 and 12

    Contributes to the alert performance criteria

  6. Appropriateness of medical management following the alert given the clinical situation (yes/no)

    Time frame: between months 3 and 12

    Contributes to the alert performance criteria

  7. Evolution of the height (cm)

    Time frame: between months 2 and 12

    Contributes to the clinical evolution criteria

  8. Evolution of the weight (kg)

    Time frame: between months 2 and 12

    Contributes to the clinical evolution criteria

  9. Evolution of oxygen saturation (SpO2, %)

    Time frame: between months 2 and 12

    Contributes to the clinical evolution criteria

  10. Evolution of the heart failure score (Ross classification)

    Time frame: between months 2 and 12

    Contributes to the clinical evolution criteria

  11. Life quality

    Time frame: between months 2 and 12

    Changes in the score of the QUALIN (QUALIté de vie du Nourrisson) validated generic quality of life proxy questionnaire: before returning home, at 3 months and at the end of the programme. The QUALIN questionnaire is a 34-item generic French QoL instrument designed for infants (aged 0-3 years). Each answer scores from -2 (totally false) to +2 (quite true). An item with a score >1 corresponds to favourable QoL.

  12. Parental anxiety

    Time frame: between months 2 and 12

    Changes in the score of the STAI (State-Trait Anwiety Inventory) parental anxiety questionnaire: state-trait anxiety inventory. The STAI questionnaire is a 40-item instrument designed for adults. Each answer score from 1 to 4. The higher the score, the less anxious the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie CHABANEIX, MD

CONTACT

[email protected]

+33 5 57 65 61 09 ext. +33

Mélissa DACCORD

CONTACT

[email protected]

+33 5 24 54 91 68 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study

Acronym: Blue-Line

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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