Cardiopediatric Home Monitoring Tool (OSCAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Heart Defect
• Intervention / Treatment: Other: usual medical monitoring; Other: Home monitoring

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 Type: Interventional
• Enrollment (Estimated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alban-Elouen Baruteau, Pr; Phone Number: +33240087742 +33; Email: albanelouen.baruteau@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • Recruiting
    • CHU de Nantes
    • Contact: Alban BARUTEAU; Phone Number: 0240087742; Email: albanelouen.baruteau@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard group; The usual medical monitoring for the first six months postoperatively is standardized between the 4 university hospital centres concerned and consists of : 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.	Other: usual 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.
Experimental: home monitoring group; 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.	Other: usual 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.; Other: Home 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6th month post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0,1 month, 3 months and 6 months post op
Parents' quality of life	Assess the impact of OSCAR surveillance by comparing the 2 groups: Parents' quality of life during the postoperative period	0,1 month, 3 months and 6 months post op
Parental stress	Assess the impact of OSCAR surveillance by comparing the 2 groups: Parental stress and family impact during the postoperative period	0,1 month, 3 months and 6 months post op
Children's weight growth	Assess the impact of OSCAR surveillance by comparing the 2 groups: Children's weight growth during the postoperative period	1 month, 3 months and 6 months post op
Post-traumatic stress syndromes	Assess the impact of OSCAR surveillance by comparing the 2 groups: The prevalence of post-traumatic stress syndromes in parents at the postoperative month.	6 months post op
Serious non-cardiovascular events	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).	6 months post op
Factors other than management	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.	6 months post op
Therapeutic education program	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.	6 months post op
Acceptability of monitoring for the parents	Evaluate the conditions for implementing OSCAR surveillance by assessing : The acceptability of monitoring for the parents in the group concerned.	6 months post op
Acceptability of the monitoring for the medical teams	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).	6 months post op
Efficiency	Evaluate the conditions for implementing OSCAR surveillance by assessing : its efficiency.	6 months post op

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Congenital heart defects, cardiac surgery, care pathway, home monitoring, morbidity and mortality
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Blood Glucose Self-Monitoring
• Other Study ID Numbers: RC24_0146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No