Cardiopediatric Home Monitoring Tool
ConditionCongenital Heart Defect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-36
SponsorNantes University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Home monitoring
Other interventionThe 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.
usual medical monitoring
Other interventionDuring 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.
Treatment groups
186 Participants
are divided into 2 treatment groupsGroup A: standard groupActive comparator 1 intervention
Group B: home monitoring groupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Reducing postoperative morbidity and mortality
The main objective is to evaluate the impact of home monitoring in reducing postoperative morbidity and mortality in patients aged 0 to 36 months who have undergone MCC.
Time frame
6th month post-opSecondary outcomes
1
Children's quality of life
Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's quality of life during the postoperative period.
Time frame
0,1 month, 3 months and 6 months post op2
Parents' quality of life
Assess the impact of OSCAR surveillance by comparing the 2 groups: Parents' quality of life during the postoperative period
Time frame
0,1 month, 3 months and 6 months post op3
Parental stress
Assess the impact of OSCAR surveillance by comparing the 2 groups: Parental stress and family impact during the postoperative period
Time frame
0,1 month, 3 months and 6 months post op4
Children's weight growth
Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's weight growth during the postoperative period
Time frame
1 month, 3 months and 6 months post opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov