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 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.

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.

It is (a) a growing patient population, due to an increase in birth prevalence and survival, and (b) a major public health issue, due to a substantial use of healthcare resources and a dramatic impact on quality of life. CHDs concerned by the OSCAR project are rare diseases (prevalence \<1/2000 births) operated on at birth or in infancy. These CHDs expose affected newborns/infants to the risk of major cardiovascular events (fainting, cyanosis, arrhythmias) and/or rapid cardiac decompensation occurring at home in the postoperative period, justifying close ambulatory monitoring to detect early warning signs of complication or decompensation (such as oxygen desaturation, accelerated heart rate, poor weight gain, altered tone, etc.)

This risk is particularly high in certain critical postoperative situations, such as when the physiology of a single ventricle is palliated by a shunt (modified Blalock-Taussig systemic-pulmonary anatomy), or in the intermediate period (interstage) between two palliative surgeries in a Norwood program. In view of the high ambulatory mortality (12-20% in current series) during the interstage of a Norwood program, some expert centers around the world have opted not to discharge operated neonates home, preferring to keep in-hospital monitoring during 4 to 5 months, until stage 2, thus reducing mortality during this critical period. In Anglo-Saxon countries, an outpatient monitoring program has been developed as an alternative for these vulnerable patients, sometimes accompanied by a telemedicine solution, greatly reducing postoperative mortality. This type of outpatient follow-up program does not exist in France.

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

Exclusion Criteria

Not provided

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.