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Cardiopediatric Home Monitoring Tool

RecruitingNAAges 0 Minutes - 36 MonthsAllNantes University Hospital
NCT06741189 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Home monitoring
  • usual medical monitoring
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Where

1 site
CHU de Nantes
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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