RecruitingNot ApplicableNCT06741189

Cardiopediatric Home Monitoring Tool


Sponsor

Nantes University Hospital

Enrollment

186 participants

Start Date

Oct 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 0 MinutesMax Age: 36 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Home monitoring and usual medical monitoring for people with congenital heart defect. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Minutes to 36 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHome monitoring

The key parameters (heart rate, arterial oxygen saturation, weight) will be measured at home using the measurement tools used by the parents, and tele-transmitted at a discontinuous rate, i.e. once a day for 4 weeks, then once a week for 20 weeks. The measurement tools will be given to the family before discharge from the hospital ward. These parameters will be entered into the Exolis platform, in addition to a very brief questionnaire designed to provide information about the child's diet, muscle tone and any medication he or she is taking. taken by the child. An alert will be automatically generated for the pediatric cardiology team if the data transmitted by the measurement sensors deviates from an individualized standard, defined for each child and/or each care pathway at the multidisciplinary consultation meeting before the child returns home. The response will be standardized on the basis of a protocol shared by the 4 investigating centers.

OTHERusual medical monitoring

During the first 4 weeks: a weekly consultation including a record of intercurrent events (malaise, cyanosis, hyperthermia, eating difficulties), a record of weight and vital constants (oxygen saturation, heart rate), an examination of the sternotomy or thoracotomy scar, a clinical cardiovascular examination, a 12-lead electrocardiogram and a transthoracic echocardiogram. During the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.


Locations(1)

CHU de Nantes

Nantes, France

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NCT06741189


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