Cardiopediatric Home Monitoring Tool

Not Applicable

Not yet recruiting

• Conditions: Congenital Heart Defect

• Registration Number: NCT06741189
• Lead Sponsor: Nantes University Hospital

Brief 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...

Detailed Description

Affecting 12-million people worldwide and 7,400 newborns/year in France, congenital heart defects (CHD) are the leading cause of birth defects and a major cause of morbidity and mortality in childhood.
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Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Study Start: 2025-04-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 186

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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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reducing postoperative morbidity and mortality	6th month post-op	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.

Secondary Outcome Measures

Name	Time	Method
Children's quality of life	0,1 month, 3 months and 6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's quality of life during the postoperative period.
Parents' quality of life	0,1 month, 3 months and 6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: Parents' quality of life during the postoperative period
Parental stress	0,1 month, 3 months and 6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: Parental stress and family impact during the postoperative period
Children's weight growth	1 month, 3 months and 6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's weight growth during the postoperative period
Post-traumatic stress syndromes	6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: The prevalence of post-traumatic stress syndromes in parents at the postoperative month.
Serious non-cardiovascular events	6 months post op	Assess the impact of OSCAR surveillance by comparing the 2 groups: The rate of serious non-cardiovascular events (in order to study a potential delay in the management of these events in the group with OSCAR monitoring group due to increased follow-up).
Factors other than management	6 months post op	To study the impact of factors other than management (OSCAR monitoring versus management) on the parents' quality of life, parental stress and family impact family impact, children's weight gain, and the presence of post-traumatic stress post-traumatic stress disorder in the parents 6 months after the operation.
Therapeutic education program	6 months post op	Evaluate the conditions for implementing OSCAR surveillance by assessing : The relevance of the OSCAR therapeutic education program (ETP) for the parents in the group concerned.
Acceptability of monitoring for the parents	6 months post op	Evaluate the conditions for implementing OSCAR surveillance by assessing : The acceptability of monitoring for the parents in the group concerned.
Acceptability of the monitoring for the medical teams	6 months post op	Evaluate the conditions for implementing OSCAR surveillance by assessing : The acceptability of the monitoring for the medical teams (investigating hospital investigating hospital medical teams and the child's routine care medical teams).
Efficiency	6 months post op	Evaluate the conditions for implementing OSCAR surveillance by assessing : its efficiency.