Home monitoring for babies after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study aims to see whether a home monitoring program, using validated sensors and an alert system tailored to each care pathway, alongside standard postoperative care, can reduce morbidity and mortality in neonates and young children after cardiac surgery. It employs a protocolized medical response to alerts generated by the home tool. The population affected includes patients with congenital heart defects, focusing on high-risk postoperative periods such as interstage periods in staged palliation. The trial is conducted at Nantes University Hospital, leveraging the Exolis home platform for remote connectivity. Primary endpoints and statistical specifics are not provided in the available material.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Alban-Elouen Baruteau, Pr
• Email: albanelouen.baruteau@chu-nantes.fr
• Phone: +33

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.