Clinical trial NCT06741189: Cardiopediatric Home Monitoring Tool
Official title: Cardiopediatric Home Monitoring Tool
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Defect
Keywords: Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 186
Sex: ALL
Minimum age (years): 0
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We hypothesize that a home monitoring program combined with routine postoperative care significantly reduces morbidity and mortality after neonatal and pediatric cardiac surgery. This project differs from the previously published experiences by (a) providing an innovative telemedicine solution via the use of validated measurement sensors, (b) an alert system based on individualized standards, established for each care pathway, and (c) a protocolized response from medical teams in the management of alerts generated by the home monitoring tool.

Detailed description: Affecting 12-million people worldwide and 7,400 newborns/year in France, congenital heart defects (CHD) are the leading cause of birth defects and a major cause of morbidity and mortality in childhood.

It is (a) a growing patient population, due to an increase in birth prevalence and survival, and (b) a major public health issue, due to a substantial use of healthcare resources and a dramatic impact on quality of life. CHDs concerned by the OSCAR project are rare diseases (prevalence \<1/2000 births) operated on at birth or in infancy. These CHDs expose affected newborns/infants to the risk of major cardiovascular events (fainting, cyanosis, arrhythmias) and/or rapid cardiac decompensation occurring at home in the postoperative period, justifying close ambulatory monitoring to detect early warning signs of complication or decompensation (such as oxygen desaturation, accelerated heart rate, poor weight gain, altered tone, etc.)

This risk is particularly high in certain critical postoperative situations, such as when the physiology of a single ventricle is palliated by a shunt (modified Blalock-Taussig systemic-pulmonary anatomy), or in the intermediate period (interstage) between two palliative surgeries in a Norwood program. In view of the high ambulatory mortality (12-20% in current series) during the interstage of a Norwood program, some expert centers around the world have opted not to discharge operated neonates home, preferring to keep in-hospital monitoring during 4 to 5 months, until stage 2, thus reducing mortality during this critical period. In Anglo-Saxon countries, an outpatient monitoring program has been developed as an alternative for these vulnerable patients, sometimes accompanied by a telemedicine solution, greatly reducing postoperative mortality. This type of outpatient follow-up program does not exist in France.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 0 and 36 months inclusive
* With a congenital heart defect
* Underwent cardiac surgery at Nantes University Hospital
* Affiliated to a social security scheme
* Free, informed and written consent of the 2 holders of parental authority

Non Inclusion Criteria:

* Clinical or family situation contraindicating a return home
* Physical inability to connect to the Exolis platform at home
* Insufficient understanding on the part of those with parental authority
* Extracardiac co-morbidities responsible for organ failure requiring repeated
* Hospitalisation for non-cardiovascular reasons (e.g. severe renal failure, neurological neurological deficit, complex immune deficiency, etc).
* Patient and/or parents under legal protection

Primary outcomes:
measure: Reducing postoperative morbidity and mortality
timeFrame: 6th month post-op
Secondary outcomes:
measure: Children's quality of life
timeFrame: 0,1 month, 3 months and 6 months post op
measure: Parents' quality of life
timeFrame: 0,1 month, 3 months and 6 months post op
measure: Parental stress
timeFrame: 0,1 month, 3 months and 6 months post op
measure: Children's weight growth
timeFrame: 1 month, 3 months and 6 months post op
measure: Post-traumatic stress syndromes
timeFrame: 6 months post op
measure: Serious non-cardiovascular events
timeFrame: 6 months post op
measure: Factors other than management
timeFrame: 6 months post op
measure: Therapeutic education program
timeFrame: 6 months post op
measure: Acceptability of monitoring for the parents
timeFrame: 6 months post op
measure: Acceptability of the monitoring for the medical teams
timeFrame: 6 months post op
measure: Efficiency
timeFrame: 6 months post op
Other outcomes:
Locations:
Study officials:
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