Home monitoring after heart surgery in babies and young children with congenital heart defects

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for babies and young children with a congenital heart defect who had heart surgery at Nantes University Hospital. It compares usual follow-up with added home monitoring.

Age

0 to 36 months inclusive

Sex

All

Disease stage

Congenital heart defect, after heart surgery at Nantes University Hospital

Earlier treatment

Must have had heart surgery at Nantes University Hospital

Main reasons for not taking part

• Health or family situation that does not allow going home
• Unable to connect to the Exolis platform at home
• Parents do not understand the study well enough
• Other organ problems outside the heart needing repeated hospital stays, such as severe kidney failure, nerve damage or complex immune deficiency
• Child or parents under legal protection

The registry criteria, word for word

What the trial wants to find out

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.

The 2 groups in the trial

• standard groupExisting treatment, for comparison

  The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of : 1. 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. 2. during the following 20 weeks: a consultation at 1, 3 and 6 months including the same assessment procedures.

  Treatment: usual medical monitoring

• home monitoring groupTreatment being tested

  In addition to the usual post-operative monitoring, OSCAR home monitoring will enable key parameters to be transmitted to the medical team at a discontinuous rate (once a day for 4 weeks, then once a week for 20 weeks) via a brief questionnaire (smartphone application) and measurement sensors (weight, oxygen saturation, heart rate) linked to an interface, from the first day the patient returns home until the 6th month post-operatively. The values entered will be automatically compared with individualized standards established for each child at a multidisciplinary meeting, and any deviation from the standard will generate an alert. and the response of the medical teams will be protocolized.

  Treatment: Home monitoring and usual medical monitoring