CHD - Congenital Heart DiseaseBlue-LineNCT06998290
Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life
A study testing Blue-Line home telemonitoring program in people with CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- CHD - Congenital Heart Disease
- What is being tested?
- Blue-Line home telemonitoring program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295 - Cedex 5
Marie VINCENTI, MD, +33 4 67 33 66 43 ext. +33, m-vincenti@chu-montpellier.fr
CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque
Pessac, France, 33604
Mélissa DACCORD, +33 5 24 54 91 68, melissa.daccord@chu-bordeaux.fr
About this study
Official title: Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study
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.
Read the 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
- Being tested
- Blue-Line home telemonitoring program
- Keywords
- Congenital heart disease, Infants, Vulnerability, Home monitoring, Therapeutic education, Digital platform
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Blue-Line programme | Experimental | Telemonitoring program Receives: Other: Blue-Line home telemonitoring program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: between inclusion visit and the last protocol visit (month 12)
Evaluation of the measurement devices: functional (yes/no)
Contributes to programme feasibility criteria
Measured: between inclusion visit and the last protocol visit (month 12)
Evaluation of the telemonitoring platform (functional/ergonomic/reliable)
Contributes to programme feasibility criteria
Measured: 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
Measured: 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
Measured: between inclusion visit and the last protocol visit (month 12)
Acceptability to parents: parent satisfaction questionnaire
Contributes to programme feasibility criteria
Measured: between inclusion visit and the last protocol visit (month 12)
Acceptability to caregivers: caregiver satisfaction questionnaire
Contributes to programme feasibility criteria
Measured: between inclusion visit and the last protocol visit (month 12)
Secondary outcomes (12)
Events of interest
Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation.
Measured: between months 3 and 12
Date of telemonitoring alert
Contributes to the alert performance criteria
Measured: between months 3 and 12
Severity level of alert (orange/red)
Contributes to the alert performance criteria
Measured: between months 3 and 12
Appropriateness of the alert (yes/no)
Contributes to the alert performance criteria
Measured: between months 3 and 12
Respect for the procedure to be followed following an alert by parents (yes/no)
Contributes to the alert performance criteria
Measured: between months 3 and 12
Appropriateness of medical management following the alert given the clinical situation (yes/no)
Contributes to the alert performance criteria
Measured: between months 3 and 12
Evolution of the height (cm)
Contributes to the clinical evolution criteria
Measured: between months 2 and 12
Evolution of the weight (kg)
Contributes to the clinical evolution criteria
Measured: between months 2 and 12
Evolution of oxygen saturation (SpO2, %)
Contributes to the clinical evolution criteria
Measured: between months 2 and 12
Evolution of the heart failure score (Ross classification)
Contributes to the clinical evolution criteria
Measured: between months 2 and 12
Life quality
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.
Measured: between months 2 and 12
Parental anxiety
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.
Measured: between months 2 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHD - Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998290
- Sponsor's protocol ID
- CHUBX 2021/41
- Other IDs
- 2024-A01759-38
- Acronym
- Blue-Line
- Status last verified
- May 2025
- First submitted
- 18 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study
- ClinicalTrials.gov ID
- NCT06998290
- Acronym / sponsor ID
- Blue-Line / CHUBX 2021/41
- Conditions
- CHD - Congenital Heart Disease
- Keywords
- Congenital heart disease, Infants, Vulnerability, Home monitoring, Therapeutic education, Digital platform
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blue-Line programme | Experimental | Other: Blue-Line home telemonitoring programTelemonitoring program |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Blue-Line programme |
Primary outcome
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
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
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
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
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
Acceptability to parents: parent satisfaction questionnaire
Time frame: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Acceptability to caregivers: caregiver satisfaction questionnaire
Time frame: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
12 secondary outcomes
Events of interest
Time frame: between months 3 and 12
Date of telemonitoring alert
Time frame: between months 3 and 12
Severity level of alert (orange/red)
Time frame: between months 3 and 12
Appropriateness of the alert (yes/no)
Time frame: between months 3 and 12
Respect for the procedure to be followed following an alert by parents (yes/no)
Time frame: between months 3 and 12
Appropriateness of medical management following the alert given the clinical situation (yes/no)
Time frame: between months 3 and 12
Evolution of the height (cm)
Time frame: between months 2 and 12
Evolution of the weight (kg)
Time frame: between months 2 and 12
Evolution of oxygen saturation (SpO2, %)
Time frame: between months 2 and 12
Evolution of the heart failure score (Ross classification)
Time frame: between months 2 and 12
Life quality
Time frame: between months 2 and 12
Parental anxiety
Time frame: between months 2 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue-Line home telemonitoring program in people with CHD - Congenital Heart Disease, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélissa DACCORD (+33 5 24 54 91 68 ext. +33, melissa.daccord@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.